The following data is part of a premarket notification filed by Avec Scientific Design Corp. with the FDA for Over Drape Leg Holder.
Device ID | K871900 |
510k Number | K871900 |
Device Name: | OVER DRAPE LEG HOLDER |
Classification | Component, Traction, Non-invasive |
Applicant | AVEC SCIENTIFIC DESIGN CORP. 605 SOUTH 19TH ST. Philadelphia, PA 19146 |
Contact | Aaron Heintz |
Correspondent | Aaron Heintz AVEC SCIENTIFIC DESIGN CORP. 605 SOUTH 19TH ST. Philadelphia, PA 19146 |
Product Code | KQZ |
CFR Regulation Number | 888.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-15 |
Decision Date | 1987-06-16 |