The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Steamplus Steam Integrator.
| Device ID | K063799 |
| 510k Number | K063799 |
| Device Name: | STEAMPLUS STEAM INTEGRATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SPS MEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD. Rush, NY 14543 |
| Contact | Gary J Socola |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-01-05 |
| Summary: | summary |