The following data is part of a premarket notification filed by American V. Mueller with the FDA for Maxivac(tm) Closed Wound Suction Drainage System.
Device ID | K873332 |
510k Number | K873332 |
Device Name: | MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Applicant | AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
Contact | Matthew Nowland |
Correspondent | Matthew Nowland AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
Product Code | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-19 |
Decision Date | 1987-09-08 |