RAPID FIRE HAIR IMPLANTER CAROUSEL
FDA 510(k) clearance K972918 · decided 1997-10-27
Clearance details
- K-number
- K972918
- Device name
- RAPID FIRE HAIR IMPLANTER CAROUSEL
- Applicant
- Apex Medical Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 1997-08-07
- Decision date
- 1997-10-27
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- GAH
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Potomac, MD, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| VENX REVOLUTION (K110355) | Venx, LLC | 2011-04-22 |
| ARACHNOPHLEBECTOMY NEEDLE (K000932) | Advanced Medical Products, Inc. | 2000-05-17 |
| MARKMAN TEMPLATE SYSTEM (K970306) | Barry Markman, M.D. | 1997-11-20 |
| NAVIGATOR (STYLET) 2006 (K972521) | Sil-Med Corp. | 1997-10-01 |
| CALVITRON HAIR TRANSPLANT SYSTEM (K952737) | Medicamat S.A. | 1995-10-03 |
| HAIR TRANSPLANT PUNCH, MULTIPLH (K770970) | Padgett Instruments, Inc. | 1977-10-27 |
Recalls involving this device
No recalls on record reference this clearance.