The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Medipart Face Mask Headstrap Mp-9100.
| Device ID | K853573 |
| 510k Number | K853573 |
| Device Name: | MEDIPART FACE MASK HEADSTRAP MP-9100 |
| Classification | Strap, Head, Gas Mask |
| 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 | BTK |
| CFR Regulation Number | 868.5560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1985-10-29 |