The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for 22mm Id/od Adapter.
Device ID | K911263 |
510k Number | K911263 |
Device Name: | 22MM ID/OD ADAPTER |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | MONAGHAN MEDICAL CORP. FRANKLYN BLDG RT. 9 NORTH P.O. BOX 978 Plattsburgh, NY 12901 |
Contact | James A Cochie |
Correspondent | James A Cochie MONAGHAN MEDICAL CORP. FRANKLYN BLDG RT. 9 NORTH P.O. BOX 978 Plattsburgh, NY 12901 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-22 |
Decision Date | 1991-08-19 |