The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Integral Disposable Holder Carpentier.
Device ID | K792034 |
510k Number | K792034 |
Device Name: | INTEGRAL DISPOSABLE HOLDER CARPENTIER |
Classification | Holder, Heart-valve, Prosthesis |
Applicant | EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTJ |
CFR Regulation Number | 870.3935 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-10 |
Decision Date | 1979-12-07 |