The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Universal Tourniquet.
Device ID | K873928 |
510k Number | K873928 |
Device Name: | UNIVERSAL TOURNIQUET |
Classification | Tourniquet, Nonpneumatic |
Applicant | DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis, IN 46236 |
Contact | Paul E Dryden |
Correspondent | Paul E Dryden DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis, IN 46236 |
Product Code | GAX |
CFR Regulation Number | 878.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-25 |
Decision Date | 1987-10-23 |