The following data is part of a premarket notification filed by Creative Contract (m) Sdn Bhd with the FDA for Dermassist Fluid Resistant Surgical Mask With Wraparound Visor.
| Device ID | K021546 |
| 510k Number | K021546 |
| Device Name: | DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR |
| Classification | Mask, Surgical |
| Applicant | CREATIVE CONTRACT (M) SDN BHD 8220 CHARLES PAGE BLVD. Sand Springs, OK 74063 |
| Contact | Mark Reiber |
| Correspondent | Mark Reiber CREATIVE CONTRACT (M) SDN BHD 8220 CHARLES PAGE BLVD. Sand Springs, OK 74063 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2003-03-05 |