Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K790770 |
Device Name |
SAFETY HOLSTER, SINGLE-USE |
Applicant |
ASPEN LABORATORIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ASPEN LABORATORIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/20/1979 |
Decision Date | 05/18/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|