The following data is part of a premarket notification filed by Lerman & Son with the FDA for Lerman & Son Cranial Orthosis Helmet.
| Device ID | K012830 |
| 510k Number | K012830 |
| Device Name: | LERMAN & SON CRANIAL ORTHOSIS HELMET |
| Classification | Orthosis, Cranial |
| Applicant | LERMAN & SON 8710 WILSHIRE BLVD. Beverly Hills, CA 90211 |
| Contact | Max Lerman |
| Correspondent | Max Lerman LERMAN & SON 8710 WILSHIRE BLVD. Beverly Hills, CA 90211 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-23 |
| Decision Date | 2001-11-20 |
| Summary: | summary |