The following data is part of a premarket notification filed by North American Sterilization & Packaging Co. with the FDA for 3-ring Handle, Grasp Forceps, Loop Retrie., Basket.
Device ID | K894986 |
510k Number | K894986 |
Device Name: | 3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET |
Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
Applicant | NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
Contact | Charles E Meisch |
Correspondent | Charles E Meisch NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
Product Code | OCZ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-08 |
Decision Date | 1989-12-01 |