CALVITRON HAIR TRANSPLANT SYSTEM
FDA 510(k) clearance K952737 · decided 1995-10-03
Clearance details
- K-number
- K952737
- Device name
- CALVITRON HAIR TRANSPLANT SYSTEM
- Applicant
- Medicamat S.A.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-15
- Decision date
- 1995-10-03
- Days to decision
- 110 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
- Washington, DC, 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 |
|---|---|---|
| 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 |
| RAPID FIRE HAIR IMPLANTER CAROUSEL (K972918) | Apex Medical Products, LLC | 1997-10-27 |
| NAVIGATOR (STYLET) 2006 (K972521) | Sil-Med Corp. | 1997-10-01 |
| HAIR TRANSPLANT PUNCH, MULTIPLH (K770970) | Padgett Instruments, Inc. | 1977-10-27 |
Recalls involving this device
No recalls on record reference this clearance.