The following data is part of a premarket notification filed by K. W. Griffen Co. with the FDA for Modified Use Of Triangle Bandage Sterile.
Device ID | K874161 |
510k Number | K874161 |
Device Name: | MODIFIED USE OF TRIANGLE BANDAGE STERILE |
Classification | Dressing, Wound, Drug |
Applicant | K. W. GRIFFEN CO. C/O CORNELIA DAMSKY, INC. 56 WESTCOTT ROAD Stamford, CT 06902 |
Contact | Cornelia Damsky |
Correspondent | Cornelia Damsky K. W. GRIFFEN CO. C/O CORNELIA DAMSKY, INC. 56 WESTCOTT ROAD Stamford, CT 06902 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-13 |
Decision Date | 1987-12-04 |