The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Sporview Culture Media.
Device ID | K890754 |
510k Number | K890754 |
Device Name: | SPORVIEW CULTURE MEDIA |
Classification | Indicator, Biological 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 | FRC |
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 | 1989-11-17 |