The following data is part of a premarket notification filed by Avec Scientific Design Corp. with the FDA for Kambin Laminectomy Frame.
Device ID | K874494 |
510k Number | K874494 |
Device Name: | KAMBIN LAMINECTOMY FRAME |
Classification | Surgical Table Cushion |
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 | LWG |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-02 |
Decision Date | 1987-11-23 |