The following data is part of a premarket notification filed by Anetec, Inc. with the FDA for Disposable Thermoplastic Anesth Breathing Circuits.
| Device ID | K891479 |
| 510k Number | K891479 |
| Device Name: | DISPOSABLE THERMOPLASTIC ANESTH BREATHING CIRCUITS |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | ANETEC, INC. P.O. BOX 991, 340 BELL BLVD. BELLEVILLE, ONTARIO K8n 5b6, CA |
| Contact | Catharine P Huff |
| Correspondent | Catharine P Huff ANETEC, INC. P.O. BOX 991, 340 BELL BLVD. BELLEVILLE, ONTARIO K8n 5b6, CA |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-16 |
| Decision Date | 1989-05-05 |