The following data is part of a premarket notification filed by American Container Technology, Inc. with the FDA for Rail Clamp Extension Piece.
Device ID | K864459 |
510k Number | K864459 |
Device Name: | RAIL CLAMP EXTENSION PIECE |
Classification | Operating Room Accessories Table Tray |
Applicant | AMERICAN CONTAINER TECHNOLOGY, INC. 111 LESTER ST. Wallington, NJ 07057 |
Contact | Herbert Schainholz |
Correspondent | Herbert Schainholz AMERICAN CONTAINER TECHNOLOGY, INC. 111 LESTER ST. Wallington, NJ 07057 |
Product Code | FWZ |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-12 |
Decision Date | 1986-12-01 |