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 |