The following data is part of a premarket notification filed by North American Sterilization & Packaging Co. with the FDA for Nortec Connecting Tube Set.
Device ID | K911865 |
510k Number | K911865 |
Device Name: | NORTEC CONNECTING TUBE SET |
Classification | Tubing, Noninvasive |
Applicant | NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
Contact | Harry A Schlakman |
Correspondent | Harry A Schlakman NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
Product Code | GAZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-26 |
Decision Date | 1991-11-01 |