The following data is part of a premarket notification filed by Spsmedical Supply Corp. with the FDA for Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators.
| Device ID | K110152 |
| 510k Number | K110152 |
| Device Name: | SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SPSMEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD Rush, NY 14543 |
| Contact | Gary J Socola |
| Correspondent | Gary J Socola SPSMEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD Rush, NY 14543 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-19 |
| Decision Date | 2011-04-15 |
| Summary: | summary |