The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Strip, Sterilization Indicator; Steam Or E.o. Gas.
| Device ID | K890765 |
| 510k Number | K890765 |
| Device Name: | STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GAS |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SPS MEDICAL SUPPLY CORP. 1250 SCOTTSVILLE RD. Rochester, NY 14624 |
| Contact | Jack Scoville |
| Correspondent | Jack Scoville SPS MEDICAL SUPPLY CORP. 1250 SCOTTSVILLE RD. Rochester, NY 14624 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-14 |
| Decision Date | 1989-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2687753001 | K890765 | 000 |
| H83435930001 | K890765 | 000 |