The following data is part of a premarket notification filed by Danmar Products, Inc. with the FDA for Danmar Products Cranial Adjustive Prosthesis.
Device ID | K013452 |
510k Number | K013452 |
Device Name: | DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS |
Classification | Orthosis, Cranial |
Applicant | DANMAR PRODUCTS, INC. 221 JACKSON INDUSTRIAL DR. Ann Arbor, MI 48103 |
Contact | Karen A Lindner |
Correspondent | Karen A Lindner DANMAR PRODUCTS, INC. 221 JACKSON INDUSTRIAL DR. Ann Arbor, MI 48103 |
Product Code | MVA |
CFR Regulation Number | 882.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-18 |
Decision Date | 2003-10-31 |
Summary: | summary |