The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Sterimed Sterization Wrapper (non-sterile).
| Device ID | K953678 |
| 510k Number | K953678 |
| Device Name: | STERIMED STERIZATION WRAPPER (NON-STERILE) |
| Classification | Wrap, Sterilization |
| Applicant | CUSTOMED, INC. CALLE INDUSTRIAL FINAL, HVY. NO.3, KM. 45.0 Fajardo, PR 00648 |
| Contact | Felixx B Santos |
| Correspondent | Felixx B Santos CUSTOMED, INC. CALLE INDUSTRIAL FINAL, HVY. NO.3, KM. 45.0 Fajardo, PR 00648 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1995-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20890010702 | K953678 | 000 |
| M2089000862 | K953678 | 000 |
| M2089000852 | K953678 | 000 |
| M2089000842 | K953678 | 000 |
| M2089000832 | K953678 | 000 |
| M2089000822 | K953678 | 000 |
| M2089000812 | K953678 | 000 |
| M2089000792 | K953678 | 000 |
| M2089000782 | K953678 | 000 |