The following data is part of a premarket notification filed by Meta Biomed, Inc. with the FDA for Md-flex Heavy Body.
| Device ID | K134008 |
| 510k Number | K134008 |
| Device Name: | MD-FLEX HEAVY BODY |
| Classification | Material, Impression |
| Applicant | META BIOMED, INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Contact | Blix Winston |
| Correspondent | Blix Winston META BIOMED, INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-30 |
| Decision Date | 2014-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387892847 | K134008 | 000 |