The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Surgical Suction Instruments-dispos..
Device ID | K812845 |
510k Number | K812845 |
Device Name: | SURGICAL SUCTION INSTRUMENTS-DISPOS. |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | ABCO DEALERS, INC. 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 | 1981-10-09 |
Decision Date | 1981-11-16 |