The following data is part of a premarket notification filed by Medcare Medical Group, Inc. with the FDA for Biopsy Tray.
| Device ID | K970152 |
| 510k Number | K970152 |
| Device Name: | BIOPSY TRAY |
| Classification | Wrap, Sterilization |
| Applicant | MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
| Contact | Craig J Bell |
| Correspondent | Craig J Bell MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-16 |
| Decision Date | 1997-03-05 |
| Summary: | summary |