The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Coopersurgical Laparoscopic Instruments.
| Device ID | K021237 |
| 510k Number | K021237 |
| Device Name: | COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | COOPERSURGICAL, INC. KAISERSTR.9 Tuningen, DE D-78609 |
| Contact | Haiko Bell |
| Correspondent | Haiko Bell COOPERSURGICAL, INC. KAISERSTR.9 Tuningen, DE D-78609 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-18 |
| Decision Date | 2003-04-10 |
| Summary: | summary |