| Device Classification Name |
Instrument, Manual, Surgical, General Use
|
| 510(k) Number |
K922874 |
| Device Name |
DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE |
| Applicant |
| Supra Instruments, Inc. |
| P.O. Box 15063 |
|
Alexandria,
VA
22309
|
|
| Applicant Contact |
BASHIR |
| Correspondent |
| Supra Instruments, Inc. |
| P.O. Box 15063 |
|
Alexandria,
VA
22309
|
|
| Correspondent Contact |
BASHIR |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 06/15/1992 |
| Decision Date | 09/11/1992 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|