The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Disposable Anesthesia Breathing Circuits, Modified.
| Device ID | K912065 |
| 510k Number | K912065 |
| Device Name: | DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | Debra E Rogers |
| Correspondent | Debra E Rogers INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-26 |
| Decision Date | 1991-10-23 |