The following data is part of a premarket notification filed by Cost Rite Health Products, Inc. with the FDA for Carerite & Cost Rite Nylon Sterilization Film.
Device ID | K870147 |
510k Number | K870147 |
Device Name: | CARERITE & COST RITE NYLON STERILIZATION FILM |
Classification | Wrap, Sterilization |
Applicant | COST RITE HEALTH PRODUCTS, INC. P.O. BOX 251 Woodland Hills, CA 91365 |
Contact | Israel Ben-tzur |
Correspondent | Israel Ben-tzur COST RITE HEALTH PRODUCTS, INC. P.O. BOX 251 Woodland Hills, CA 91365 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-13 |
Decision Date | 1987-04-23 |