The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Boston Liquid Enzymatic Cleaner.
Device ID | K973217 |
510k Number | K973217 |
Device Name: | BOSTON LIQUID ENZYMATIC CLEANER |
Classification | Accessories, Soft Lens Products |
Applicant | POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
Contact | Douglas J Fortunato |
Correspondent | Douglas J Fortunato POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-27 |
Decision Date | 1997-11-24 |
Summary: | summary |