The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Lap Sponge.
Device ID | K782107 |
510k Number | K782107 |
Device Name: | LAP SPONGE |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | CARAPACE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GER |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-19 |
Decision Date | 1979-02-16 |