The following data is part of a premarket notification filed by Richard Hamer Assoc., Inc. with the FDA for Mesalt Sterile Dressing.
Device ID | K934839 |
510k Number | K934839 |
Device Name: | MESALT STERILE DRESSING |
Classification | Bandage, Liquid |
Applicant | RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 -0598 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 -0598 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-08 |
Decision Date | 1993-12-22 |