The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Disposable Latex Bandage.
Device ID | K842301 |
510k Number | K842301 |
Device Name: | DISPOSABLE LATEX BANDAGE |
Classification | Tape And Bandage, Adhesive |
Applicant | INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
Contact | Flo Becker |
Correspondent | Flo Becker INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-11 |
Decision Date | 1984-11-05 |