The following data is part of a premarket notification filed by Cox-uphuff Intl. with the FDA for Ds-7 Closed Wound Suction Drain System.
Device ID | K813394 |
510k Number | K813394 |
Device Name: | DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | COX-UPHUFF INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-12-04 |
Decision Date | 1982-01-22 |