The following data is part of a premarket notification filed by Apex Medical Products, Llc. with the FDA for Rapid Fire Hair Implanter Carousel.
| Device ID | K972918 |
| 510k Number | K972918 |
| Device Name: | RAPID FIRE HAIR IMPLANTER CAROUSEL |
| Classification | Stylet, Surgical, General & Plastic Surgery |
| Applicant | APEX MEDICAL PRODUCTS, LLC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman R Estrin |
| Correspondent | Norman R Estrin APEX MEDICAL PRODUCTS, LLC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | GAH |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-07 |
| Decision Date | 1997-10-27 |
| Summary: | summary |