The following data is part of a premarket notification filed by Moyco Union Broach, Div., Moyco Technologies, Inc. with the FDA for Integrator.
Device ID | K950646 |
510k Number | K950646 |
Device Name: | INTEGRATOR |
Classification | Manipulator, Plunger-like Joint |
Applicant | MOYCO UNION BROACH, DIV., MOYCO TECHNOLOGIES, INC. 589 DAVIES DR. York, PA 17402 |
Contact | Chris M Lehr |
Correspondent | Chris M Lehr MOYCO UNION BROACH, DIV., MOYCO TECHNOLOGIES, INC. 589 DAVIES DR. York, PA 17402 |
Product Code | LXM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-13 |
Decision Date | 1996-04-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H834015996131 | K950646 | 000 |
H834015996121 | K950646 | 000 |
H834015996030 | K950646 | 000 |
H834015996000 | K950646 | 000 |