The following data is part of a premarket notification filed by Merlin Group Dba Mcmerlin Dental Company with the FDA for Sock It! Oral Pain Gel.
| Device ID | K063148 |
| 510k Number | K063148 |
| Device Name: | SOCK IT! ORAL PAIN GEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | MERLIN GROUP DBA MCMERLIN DENTAL COMPANY 1610 W. POLO RD SUITE A Grand Prairie, TX 75052 |
| Contact | Eileen Vennum |
| Correspondent | Eileen Vennum MERLIN GROUP DBA MCMERLIN DENTAL COMPANY 1610 W. POLO RD SUITE A Grand Prairie, TX 75052 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-10-16 |
| Decision Date | 2007-01-17 |
| Summary: | summary |