FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
K Number: K884357
·
Decision Nov 1, 1988
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
7
Applicant Total
25
Review Days
15
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Basic Information
- Device Name
- PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
- K Number
- K884357
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3490
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Precision Dynamics Corp.
- Date Received
- October 17, 1988
- Decision Date
- November 1, 1988
- Product Code
- KOT
- Advisory Committee
- Dental
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOT), ordered by most recent decision date.
SUPER POLI-GRIP DENTURE ADHESIVE CREAM
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MPI DENTURE ADHESIVE FILM SEALS
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SUPER STRENGTH DENTURE ADHESIVE CREAM
FDA 510(k)
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STEADFAST DENTURE ADHESIVE CREAM
FDA 510(k)
FDA Class 1
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SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER
FDA 510(k)
FDA Class 1
·Dental
RIGIDENT CREAM
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Precision Dynamics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | Jun 3, 2002 | Substantially Equivalent |
| K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | Mar 22, 2000 | Substantially Equivalent |
| K994263 | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 | Jan 24, 2000 | Substantially Equivalent |
| K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 | Apr 6, 1999 | Substantially Equivalent |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | Jul 8, 1988 | Substantially Equivalent |
| K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY | Jan 20, 1988 | Unknown |
| K873369 | SECURLINE FRANSEENE NEEDLE | Oct 20, 1987 | Substantially Equivalent |
| K872507 | PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II | Jul 9, 1987 | Substantially Equivalent |
| K863164 | AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA | Aug 27, 1986 | Substantially Equivalent |
| K851364 | FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP | Apr 22, 1985 | Substantially Equivalent |