The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Dexide Dis. Sur. Scrub Sponge W/parachlo.
Device ID | K792272 |
510k Number | K792272 |
Device Name: | DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | DEXIDE, 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 | 1979-11-13 |
Decision Date | 1979-12-27 |