The following data is part of a premarket notification filed by Mcmerlin Dental Products Lp with the FDA for Sockit! And Mcmerlin Dermal Wound Gel.
Device ID | K090092 |
510k Number | K090092 |
Device Name: | SOCKIT! AND MCMERLIN DERMAL WOUND GEL |
Classification | Dressing, Wound, Drug |
Applicant | MCMERLIN DENTAL PRODUCTS LP 1610 WEST POLO RD. Grand Prairie, TX 75052 |
Contact | Aaron Hendershott |
Correspondent | Aaron Hendershott MCMERLIN DENTAL PRODUCTS LP 1610 WEST POLO RD. Grand Prairie, TX 75052 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2009-01-14 |
Decision Date | 2009-05-11 |
Summary: | summary |