The following data is part of a premarket notification filed by Medical Marketing Concepts with the FDA for Peep Valve.
Device ID | K961867 |
510k Number | K961867 |
Device Name: | PEEP VALVE |
Classification | Attachment, Breathing, Positive End Expiratory Pressure |
Applicant | MEDICAL MARKETING CONCEPTS 2310 YORK RD. Roanoke, VA 24015 |
Contact | Bob Martin |
Correspondent | Bob Martin MEDICAL MARKETING CONCEPTS 2310 YORK RD. Roanoke, VA 24015 |
Product Code | BYE |
CFR Regulation Number | 868.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-15 |
Decision Date | 1996-08-13 |