SHAVE PREP
FDA 510(k) clearance K780604 · decided 1978-04-19
Clearance details
- K-number
- K780604
- Device name
- SHAVE PREP
- Applicant
- Abco Dealers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-04-10
- Decision date
- 1978-04-19
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- KXF
- Device class
- 1
- Regulation number
- 880.6025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FINN CHAMBERS AQUA (K123184) | Smartpractice | 2012-12-19 |
| ALLERGEAZE R CLEAR (K103409) | Smartpractice | 2011-03-15 |
| ALLERGEAZE PATCH TEST CHAMBERS (K063160) | Smartpractice | 2006-12-22 |
| FINN CHAMBER (R) (K013820) | Epitest Ltd. OY | 2002-01-30 |
| IQ CHAMBERS (K992553) | Dormer Laboratories, Inc. | 2000-04-12 |
| EAR APPLICATOR, CATALOG NO. 2229 (K870762) | Treace Medical, Inc. | 1987-03-06 |
| COTTON TIPPED APPLICATORS, SINGLE (K843720) | Abco Dealers, Inc. | 1984-10-04 |
| COTTON SWABS (K820962) | Dafoe & Dafoe, Inc. | 1982-04-20 |
| FARRORS TMJ CASSETTE HOLDER (K813506) | Brell Mar Products, Inc. | 1982-01-29 |
| HILL TOP CHAMBER (K811365) | Hill Top Research, Inc. | 1981-08-20 |
| SUBCLAVIAN CATHETER INSERTION TRAY (K802580) | American Pharmaseal Div. Ahsc | 1980-11-12 |
| EYE APPLICATORS CAT.#980-983 (K802016) | Pollak (Intl.), Ltd. | 1980-09-16 |
Recalls involving this device
No recalls on record reference this clearance.