The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for P.e.e.p. Valve.
| Device ID | K882219 |
| 510k Number | K882219 |
| Device Name: | P.E.E.P. VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
| Contact | Tom Fangrow |
| Correspondent | Tom Fangrow LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-26 |
| Decision Date | 1988-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30026072001470 | K882219 | 000 |