The following data is part of a premarket notification filed by Look, Inc. with the FDA for Look Spring-assist Syringes.
Device ID | K872944 |
510k Number | K872944 |
Device Name: | LOOK SPRING-ASSIST SYRINGES |
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 | 1987-07-28 |
Decision Date | 1987-09-04 |