FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HEXIDIS ALCOHOL SWAB
K Number: K910735
·
Decision Apr 2, 1991
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
21
Review Days
40
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Basic Information
- Device Name
- HEXIDIS ALCOHOL SWAB
- K Number
- K910735
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Specialites Septodont
- Date Received
- February 21, 1991
- Decision Date
- April 2, 1991
- Product Code
- LKB
- Advisory Committee
- Unknown
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | FDA unclassified | Unknown |
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Other Clearances by Specialites Septodont
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|---|---|---|---|
| K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | Oct 9, 2001 | Substantially Equivalent |
| K010415 | ISODAN | Jul 23, 2001 | Substantially Equivalent |
| K982773 | QUICKSET LIQUID AND POWDER | Nov 3, 1998 | Substantially Equivalent |
| K982671 | SECURALLOY | Oct 19, 1998 | Substantially Equivalent |
| K980633 | ENDOSOLV E | May 1, 1998 | Substantially Equivalent |
| K920692 | SEPTOCALCINE ULTRA | Apr 21, 1992 | Substantially Equivalent |
| K915467 | CIMPAT S DENTAL CEMENT | Feb 3, 1992 | Substantially Equivalent |
| K915466 | SEPTOPACK TEMPORARY FILLING | Feb 3, 1992 | Substantially Equivalent |
| K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | Nov 7, 1991 | Substantially Equivalent |
| K913572 | AUTOPACK NON-EUGENOL PERIODONTAL DRESSING | Oct 9, 1991 | Substantially Equivalent |