MARKMAN TEMPLATE SYSTEM
FDA 510(k) clearance K970306 · decided 1997-11-20
Clearance details
- K-number
- K970306
- Device name
- MARKMAN TEMPLATE SYSTEM
- Applicant
- Barry Markman, M.D.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-27
- Decision date
- 1997-11-20
- Days to decision
- 297 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
- Las Vegas, NV, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Barry Markman
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| RAPID FIRE HAIR IMPLANTER CAROUSEL (K972918) | Apex Medical Products, LLC | 1997-10-27 |
| 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.