The following data is part of a premarket notification filed by Oem Medical Div. with the FDA for Oem Medical Adult Anesthesia Breathing Circuit.
Device ID | K925893 |
510k Number | K925893 |
Device Name: | OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
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 | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-17 |
Decision Date | 1993-03-12 |