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 |