The following data is part of a premarket notification filed by Transcoject Gmbh & Co. Kg with the FDA for Disposable Plastic Syringes.
Device ID | K851523 |
510k Number | K851523 |
Device Name: | DISPOSABLE PLASTIC SYRINGES |
Classification | Syringe, Piston |
Applicant | TRANSCOJECT GMBH & CO. KG RUGENSTRASSE 8 Neumuenster, DE 24539 |
Contact | O Kohler |
Correspondent | O Kohler TRANSCOJECT GMBH & CO. KG RUGENSTRASSE 8 Neumuenster, DE 24539 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-16 |
Decision Date | 1985-07-24 |