The following data is part of a premarket notification filed by Arc Medical, Inc. with the FDA for Xtend Circuits (tm).
| Device ID | K924627 |
| 510k Number | K924627 |
| Device Name: | XTEND CIRCUITS (TM) |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | ARC MEDICAL, INC. 735 PARK NORTH BLVD. BLDG 126 Clarkston, GA 30021 |
| Contact | Hal Norris |
| Correspondent | Hal Norris ARC MEDICAL, INC. 735 PARK NORTH BLVD. BLDG 126 Clarkston, GA 30021 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-14 |
| Decision Date | 1993-04-07 |