The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Penlon Circle System.
| Device ID | K864588 |
| 510k Number | K864588 |
| Device Name: | PENLON CIRCLE SYSTEM |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Wond |
| Correspondent | Wond BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-21 |
| Decision Date | 1987-02-03 |