The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Pneumo-seal(tm).
| Device ID | K914470 |
| 510k Number | K914470 |
| Device Name: | PNEUMO-SEAL(TM) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Contact | Glenn M Mattei |
| Correspondent | Glenn M Mattei EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-07 |
| Decision Date | 1991-11-29 |