The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Mp-xmm Disposable Face Mask.
Device ID | K862781 |
510k Number | K862781 |
Device Name: | MP-XMM DISPOSABLE FACE MASK |
Classification | Mask, Gas, Anesthetic |
Applicant | MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
Contact | Jerry Alexander |
Correspondent | Jerry Alexander MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
Product Code | BSJ |
CFR Regulation Number | 868.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-23 |
Decision Date | 1986-08-01 |