The following data is part of a premarket notification filed by Alta Medical Products, Inc. with the FDA for Alta Dressing Frame.
Device ID | K926380 |
510k Number | K926380 |
Device Name: | ALTA DRESSING FRAME |
Classification | Bandage, Liquid |
Applicant | ALTA MEDICAL PRODUCTS, INC. 8378 AZUL WAY Sandy, UT 84093 |
Contact | Warren Hansen |
Correspondent | Warren Hansen ALTA MEDICAL PRODUCTS, INC. 8378 AZUL WAY Sandy, UT 84093 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-22 |
Decision Date | 1993-08-06 |