The following data is part of a premarket notification filed by Elof Hansson, Inc. with the FDA for Laporatomy Sponges Sizes:18x18,12x12,4x18,8x36.
| Device ID | K864529 |
| 510k Number | K864529 |
| Device Name: | LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 |
| Classification | Gauze/sponge, Internal, With Drug/biologic, Animal Source Material |
| Applicant | ELOF HANSSON, INC. 25 VAN ZANT ST. Norwalk, CT 06855 |
| Contact | Gay Clarke |
| Correspondent | Gay Clarke ELOF HANSSON, INC. 25 VAN ZANT ST. Norwalk, CT 06855 |
| Product Code | GEL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-17 |
| Decision Date | 1986-12-16 |