The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for Benz 38 Clear & With Blue Visibility Tint.
Device ID | K961103 |
510k Number | K961103 |
Device Name: | BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. 235 NORTH TALBOT CT. Roswell, GA 30076 -1668 |
Contact | Wally Stirling |
Correspondent | Wally Stirling BENZ RESEARCH AND DEVELOPMENT CORP. 235 NORTH TALBOT CT. Roswell, GA 30076 -1668 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-20 |
Decision Date | 1996-08-23 |
Summary: | summary |