FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY
K Number: K874665
·
Decision Jan 20, 1988
Classifications
1
FEI Numbers
285
Registration Numbers
286
Same Product Code
21
Applicant Total
25
Review Days
68
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Basic Information
- Device Name
- SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY
- K Number
- K874665
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Precision Dynamics Corp.
- Date Received
- November 13, 1987
- Decision Date
- January 20, 1988
- Product Code
- LRP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRP | Tray, Surgical | FDA class 1 | General, Plastic Surgery |
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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 |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Nov 1, 1988 | Substantially Equivalent |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | Jul 8, 1988 | Substantially Equivalent |
| 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 |