The following data is part of a premarket notification filed by Center For Orthotic And Prosthetic Care,llc with the FDA for Copc Band.
| Device ID | K021594 |
| 510k Number | K021594 |
| Device Name: | COPC BAND |
| Classification | Orthosis, Cranial |
| Applicant | CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC 2525 NORTH TENTH ST. #804 Arlington, VA 22201 |
| Contact | Joseph Terpenning |
| Correspondent | Joseph Terpenning CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC 2525 NORTH TENTH ST. #804 Arlington, VA 22201 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-15 |
| Decision Date | 2003-11-13 |
| Summary: | summary |