The following data is part of a premarket notification filed by Spenco Medical Corp. with the FDA for Gelskin.
Device ID | K791162 |
510k Number | K791162 |
Device Name: | GELSKIN |
Classification | Pack, Hot Or Cold, Water Circulating |
Applicant | SPENCO MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILO |
CFR Regulation Number | 890.5720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-25 |
Decision Date | 1979-09-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GELSKIN 86078188 not registered Dead/Abandoned |
Springs Creative Products Group, LLC 2013-09-30 |