The following data is part of a premarket notification filed by Engineered Custom Mfg., Inc. with the FDA for Steritite Sealed Container(sc08f,sc06f,sc04f,sc08q,sc06q,sc04q,sc08h,sc06h,sc04h).
| Device ID | K960738 |
| 510k Number | K960738 |
| Device Name: | STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | ENGINEERED CUSTOM MFG., INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 |
| Contact | Allan Frieze |
| Correspondent | Tania Lupu ENGINEERED CUSTOM MFG., INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-23 |
| Decision Date | 1997-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994731425 | K960738 | 000 |
| 00643169225466 | K960738 | 000 |
| 00643169220768 | K960738 | 000 |
| 00643169220751 | K960738 | 000 |
| 00763000231071 | K960738 | 000 |
| 00763000210588 | K960738 | 000 |
| 00763000206567 | K960738 | 000 |
| 00763000205959 | K960738 | 000 |
| 00763000205546 | K960738 | 000 |
| 00763000057909 | K960738 | 000 |
| 00763000213688 | K960738 | 000 |
| 00643169229655 | K960738 | 000 |
| 00643169308923 | K960738 | 000 |
| 00643169310322 | K960738 | 000 |
| 00613994731418 | K960738 | 000 |
| 00613994731401 | K960738 | 000 |
| 00613994731395 | K960738 | 000 |
| 00613994993595 | K960738 | 000 |
| 00613994993564 | K960738 | 000 |
| 00643169636606 | K960738 | 000 |
| 00643169636309 | K960738 | 000 |
| 00643169636286 | K960738 | 000 |
| 00643169319875 | K960738 | 000 |
| 00643169310407 | K960738 | 000 |
| 00763000213671 | K960738 | 000 |