The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for One-way Valve (with Connector).
| Device ID | K970780 |
| 510k Number | K970780 |
| Device Name: | ONE-WAY VALVE (WITH CONNECTOR) |
| Classification | Valve, Non-rebreathing |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Lori Zuravleff |
| Correspondent | Lori Zuravleff INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-09-18 |