The following data is part of a premarket notification filed by Globalmedia Group, Llc with the FDA for Derma Hood.
| Device ID | K131338 |
| 510k Number | K131338 |
| Device Name: | DERMA HOOD |
| Classification | Accessories To Examination Light |
| Applicant | GLOBALMEDIA GROUP, LLC 15020 N. 74TH ST. Scottsdale, AZ 85260 |
| Contact | Nicholas Campbell |
| Correspondent | Nicholas Campbell GLOBALMEDIA GROUP, LLC 15020 N. 74TH ST. Scottsdale, AZ 85260 |
| Product Code | PEQ |
| CFR Regulation Number | 880.6320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-09 |
| Decision Date | 2013-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850033167122 | K131338 | 000 |