The following data is part of a premarket notification filed by Wilson Greatbatch Technologies, Inc. with the FDA for Greatbatch Scientific Mr Compatible Hysteroscope.
| Device ID | K971374 |
| 510k Number | K971374 |
| Device Name: | GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | WILSON GREATBATCH TECHNOLOGIES, INC. 4100 BARTON RD. Clarence, NY 14031 |
| Contact | Gary J Sfeir |
| Correspondent | Gary J Sfeir WILSON GREATBATCH TECHNOLOGIES, INC. 4100 BARTON RD. Clarence, NY 14031 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-14 |
| Decision Date | 1998-05-13 |
| Summary: | summary |