The following data is part of a premarket notification filed by Anacom General Corp. with the FDA for Dermatek 4000.
| Device ID | K911057 |
| 510k Number | K911057 |
| Device Name: | DERMATEK 4000 |
| Classification | Bed, Air Fluidized |
| Applicant | ANACOM GENERAL CORP. 1335 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Contact | William K Haines |
| Correspondent | William K Haines ANACOM GENERAL CORP. 1335 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Product Code | INX |
| CFR Regulation Number | 890.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-08 |
| Decision Date | 1991-04-05 |