The following data is part of a premarket notification filed by Look, Inc. with the FDA for Look Capsule Polishers/scrapers.
Device ID | K870437 |
510k Number | K870437 |
Device Name: | LOOK CAPSULE POLISHERS/SCRAPERS |
Classification | Curette, Ophthalmic |
Applicant | LOOK, INC. 45 CHARLES PARK RD. Boston, MA 02132 |
Contact | David H Barrett |
Correspondent | David H Barrett LOOK, INC. 45 CHARLES PARK RD. Boston, MA 02132 |
Product Code | HNZ |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-03 |
Decision Date | 1987-02-20 |