The following data is part of a premarket notification filed by Genetic Laboratories Wound Care, Inc. with the FDA for Lc Strip.
Device ID | K923358 |
510k Number | K923358 |
Device Name: | LC STRIP |
Classification | Tape And Bandage, Adhesive |
Applicant | GENETIC LABORATORIES WOUND CARE, INC. 2726 PATTON RD. St. Paul, MN 55113 -1136 |
Contact | Jim Thompson |
Correspondent | Jim Thompson GENETIC LABORATORIES WOUND CARE, INC. 2726 PATTON RD. St. Paul, MN 55113 -1136 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-08 |
Decision Date | 1993-01-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LC STRIP 75112983 2055254 Dead/Cancelled |
Genetic Laboratories Wound Care Inc. 1996-06-03 |