The following data is part of a premarket notification filed by Scott E Allen Cp with the FDA for Plagiocephalic Applied Pressure Orthosis P.a.p. Orthosis.
| Device ID | K012804 |
| 510k Number | K012804 |
| Device Name: | PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS |
| Classification | Orthosis, Cranial |
| Applicant | SCOTT E ALLEN CP 50 SOUTH 900 EAST #1 Salt Lake City, UT 84102 |
| Contact | Scott E Allen |
| Correspondent | Scott E Allen SCOTT E ALLEN CP 50 SOUTH 900 EAST #1 Salt Lake City, UT 84102 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-21 |
| Decision Date | 2002-01-17 |
| Summary: | summary |