The following data is part of a premarket notification filed by Guardian Angel Products, Inc. with the FDA for Guardian Gel, Surgeon's Gloving Cream.
Device ID | K910687 |
510k Number | K910687 |
Device Name: | GUARDIAN GEL, SURGEON'S GLOVING CREAM |
Classification | Cream, Gloving, Surgeon's |
Applicant | GUARDIAN ANGEL PRODUCTS, INC. COLUMBIA SQUARE 555 THIRTEETH STREET NW Washington, DC 20004 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein GUARDIAN ANGEL PRODUCTS, INC. COLUMBIA SQUARE 555 THIRTEETH STREET NW Washington, DC 20004 |
Product Code | KGQ |
CFR Regulation Number | 878.4470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-19 |
Decision Date | 1991-10-11 |