The following data is part of a premarket notification filed by Contour Fabricators, Inc. with the FDA for Instrument Holder.
| Device ID | K970900 |
| 510k Number | K970900 |
| Device Name: | INSTRUMENT HOLDER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CONTOUR FABRICATORS, INC. 4100 E. BALDWIN AVE. P.O. BOX 56 Grand Blanc, MI 48439 |
| Contact | Michael Czop |
| Correspondent | Michael Czop CONTOUR FABRICATORS, INC. 4100 E. BALDWIN AVE. P.O. BOX 56 Grand Blanc, MI 48439 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-11 |
| Decision Date | 1997-05-22 |
| Summary: | summary |