The following data is part of a premarket notification filed by Eagle Medical, Inc. with the FDA for Sterile Gauze Pads.
Device ID | K915591 |
510k Number | K915591 |
Device Name: | STERILE GAUZE PADS |
Classification | Gauze / Sponge,nonresorbable For External Use |
Applicant | EAGLE MEDICAL, INC. 160 CORPORATE WOODS COURT P.O. BOX 640 Bridgeton, MO 63044 |
Contact | Arnold Lerman |
Correspondent | Arnold Lerman EAGLE MEDICAL, INC. 160 CORPORATE WOODS COURT P.O. BOX 640 Bridgeton, MO 63044 |
Product Code | NAB |
CFR Regulation Number | 878.4014 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-13 |
Decision Date | 1993-01-27 |