The following data is part of a premarket notification filed by Specialty Medical Products Co. with the FDA for Perforated Soaking Tube.
Device ID | K874596 |
510k Number | K874596 |
Device Name: | PERFORATED SOAKING TUBE |
Classification | Catheter, Continuous Irrigation |
Applicant | SPECIALTY MEDICAL PRODUCTS CO. 3063 SOUTH DAVIS BLVD. Bountiful, UT 84010 |
Contact | Thomas J Haslam |
Correspondent | Thomas J Haslam SPECIALTY MEDICAL PRODUCTS CO. 3063 SOUTH DAVIS BLVD. Bountiful, UT 84010 |
Product Code | GBQ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-09 |
Decision Date | 1987-12-02 |