The following data is part of a premarket notification filed by The Lifeguard Store, Inc. with the FDA for Seal Rite Non-rebreathing Valve.
| Device ID | K152521 |
| 510k Number | K152521 |
| Device Name: | Seal Rite Non-Rebreathing Valve |
| Classification | Valve, Non-rebreathing |
| Applicant | The Lifeguard Store, Inc. 2012 W. College Ave. Normal, IL 61761 |
| Contact | Amy Hilten |
| Correspondent | Jennifer J. Hennessy Quarles & Brady, LLP 33 E Main Street, Suite 900 Madison, WI 53703 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2016-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872101208 | K152521 | 000 |