The following data is part of a premarket notification filed by Look, Inc. with the FDA for Ophthalmic Pao Valve.
Device ID | K882536 |
510k Number | K882536 |
Device Name: | OPHTHALMIC PAO VALVE |
Classification | Syringe, Piston |
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 | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-21 |
Decision Date | 1988-09-09 |