The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Lap-wave 3000 (p07).
| Device ID | K990732 |
| 510k Number | K990732 |
| Device Name: | LAP-WAVE 3000 (P07) |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH 194 BRANCH ST. Mansfield, MA 02048 |
| Contact | Michael Mcgrail |
| Correspondent | Michael Mcgrail W.O.M. WORLD OF MEDICINE, GMBH 194 BRANCH ST. Mansfield, MA 02048 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-05 |
| Decision Date | 1999-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702001742 | K990732 | 000 |
| 04056702000622 | K990732 | 000 |