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 |