The following data is part of a premarket notification filed by Klockner Contract Packaging, Inc. with the FDA for Swirl - A Pre-moistened Cleaning Tissue For Eyes.
Device ID | K874681 |
510k Number | K874681 |
Device Name: | SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES |
Classification | Lens, Spectacle, Non-custom (prescription) |
Applicant | KLOCKNER CONTRACT PACKAGING, INC. 5300 KLOCKNER DR. P.O. BOX 38100 Richmond, VA 23231 |
Contact | G Bacon,rph |
Correspondent | G Bacon,rph KLOCKNER CONTRACT PACKAGING, INC. 5300 KLOCKNER DR. P.O. BOX 38100 Richmond, VA 23231 |
Product Code | HQG |
CFR Regulation Number | 886.5844 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-13 |
Decision Date | 1988-02-05 |