The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Cross-checks.
| Device ID | K951113 |
| 510k Number | K951113 |
| Device Name: | CROSS-CHECKS |
| Classification | Indicator, Sterilization |
| Applicant | STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY SUITE 600 Castle Rock, CO 80104 |
| Contact | Tom Roll |
| Correspondent | Tom Roll STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY SUITE 600 Castle Rock, CO 80104 |
| Product Code | LRT |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-10 |
| Decision Date | 1996-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30809160002524 | K951113 | 000 |
| H816SM43402 | K951113 | 000 |
| H816PIT3401 | K951113 | 000 |
| H816PIT1201 | K951113 | 000 |
| H816PIT1002 | K951113 | 000 |
| H816MSM43402 | K951113 | 000 |