The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Syringe, Disposable.
Device ID | K771888 |
510k Number | K771888 |
Device Name: | SYRINGE, DISPOSABLE |
Classification | Syringe, Piston |
Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-05 |
Decision Date | 1977-10-21 |