The following data is part of a premarket notification filed by Laparomed Corp. with the FDA for Fascia Stitcher.
| Device ID | K934527 |
| 510k Number | K934527 |
| Device Name: | FASCIA STITCHER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LAPAROMED CORP. 9272 JERONIMO RD., UNIT 109 Irvine, CA 92718 |
| Contact | Paul Lublock |
| Correspondent | Paul Lublock LAPAROMED CORP. 9272 JERONIMO RD., UNIT 109 Irvine, CA 92718 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-20 |
| Decision Date | 1994-02-25 |