The following data is part of a premarket notification filed by Inamed Development Co. with the FDA for Inamed Convertible Drain System.
Device ID | K901764 |
510k Number | K901764 |
Device Name: | INAMED CONVERTIBLE DRAIN SYSTEM |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Applicant | INAMED DEVELOPMENT CO. 1035 A. CINDY LN. Carpinteria, CA 93013 |
Contact | Ellen Duke |
Correspondent | Ellen Duke INAMED DEVELOPMENT CO. 1035 A. CINDY LN. Carpinteria, CA 93013 |
Product Code | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-18 |
Decision Date | 1990-05-07 |