The following data is part of a premarket notification filed by Richard Wolf Gmbh with the FDA for Miniature Laparoscope Set (mini Lap).
| Device ID | K962799 |
| 510k Number | K962799 |
| Device Name: | MINIATURE LAPAROSCOPE SET (MINI LAP) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | RICHARD WOLF GMBH PFORZHEIMER STR. 32 Knittlingen, DE 75438 |
| Contact | Reiner Hoffmann |
| Correspondent | Reiner Hoffmann RICHARD WOLF GMBH PFORZHEIMER STR. 32 Knittlingen, DE 75438 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-18 |
| Decision Date | 1996-10-11 |
| Summary: | summary |