Device Classification Name |
stylet, surgical, general & plastic surgery
|
510(k) Number |
K972918 |
Device Name |
RAPID FIRE HAIR IMPLANTER CAROUSEL |
Applicant |
APEX MEDICAL PRODUCTS, LLC. |
9109 COPENHAVER DR. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
NORMAN R ESTRIN |
Correspondent |
APEX MEDICAL PRODUCTS, LLC. |
9109 COPENHAVER DR. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
NORMAN R ESTRIN |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/07/1997 |
Decision Date | 10/27/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|