The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Centracath #130,135 & 137-hemocath #.
Device ID | K833079 |
510k Number | K833079 |
Device Name: | CENTRACATH #130,135 & 137-HEMOCATH # |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | EXCO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-09 |
Decision Date | 1983-12-29 |