The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Verres Needle, Cannula For M820, Cannula W/trumpet Valve For M 820.
| Device ID | K971837 |
| 510k Number | K971837 |
| Device Name: | VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
| Contact | Debra A Pekar |
| Correspondent | Debra A Pekar COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1997-08-06 |
| Summary: | summary |