The following data is part of a premarket notification filed by Asia Dynamics, Inc. with the FDA for Hemo-barrier.
Device ID | K953500 |
510k Number | K953500 |
Device Name: | HEMO-BARRIER |
Classification | Bandage, Liquid |
Applicant | ASIA DYNAMICS, INC. 5745 WEST HOWARD ST. Niles, IL 60714 |
Contact | Christi Gerard |
Correspondent | Christi Gerard ASIA DYNAMICS, INC. 5745 WEST HOWARD ST. Niles, IL 60714 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-26 |
Decision Date | 1996-01-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HEMO-BARRIER 74565153 not registered Dead/Abandoned |
HEMO-BARRIER TECHNOLOGIES, INC. 1994-08-24 |