The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Meadox Surgimed Biopsy Gun Iii.
| Device ID | K922879 |
| 510k Number | K922879 |
| Device Name: | MEADOX SURGIMED BIOPSY GUN III |
| Classification | Instrument, Biopsy |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Patrician Christian |
| Correspondent | Patrician Christian MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-15 |
| Decision Date | 1992-09-01 |