The following data is part of a premarket notification filed by Oem Medical Div. with the FDA for Oem Multi-vac Powered Suction Pump.
Device ID | K924570 |
510k Number | K924570 |
Device Name: | OEM MULTI-VAC POWERED SUCTION PUMP |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | OEM MEDICAL DIV. 8741 LANDMARK RD. P.O. BOX 27604 Richmond, VA 23228 |
Contact | Jerry W Scheib |
Correspondent | Jerry W Scheib OEM MEDICAL DIV. 8741 LANDMARK RD. P.O. BOX 27604 Richmond, VA 23228 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-10 |
Decision Date | 1993-08-05 |