The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Spsmedical Airview Bowie Dick Test Pack.
| Device ID | K041017 |
| 510k Number | K041017 |
| Device Name: | SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SPS MEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD. Rush, NY 14543 |
| Contact | Gary J Socola |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-20 |
| Decision Date | 2004-06-25 |
| Summary: | summary |