The following data is part of a premarket notification filed by Byron Medical with the FDA for Elastic Adhesive Bandage.
Device ID | K910436 |
510k Number | K910436 |
Device Name: | ELASTIC ADHESIVE BANDAGE |
Classification | Tape And Bandage, Adhesive |
Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
Contact | Economidy, Jr. |
Correspondent | Economidy, Jr. BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-31 |
Decision Date | 1991-03-19 |