The following data is part of a premarket notification filed by Orthomerica Products, Inc. with the FDA for Clarren Helmet (orthomerica).
| Device ID | K021918 |
| 510k Number | K021918 |
| Device Name: | CLARREN HELMET (ORTHOMERICA) |
| Classification | Orthosis, Cranial, Laser Scan |
| Applicant | ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL Orlando, FL 32810 |
| Contact | Deanna Fish |
| Correspondent | Deanna Fish ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL Orlando, FL 32810 |
| Product Code | OAN |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-11 |
| Decision Date | 2002-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B15170905A0 | K021918 | 000 |
| B15170405A0 | K021918 | 000 |
| B15170305A0 | K021918 | 000 |