510(k) K874596
K874596 is an FDA 510(k) premarket notification submitted by Specialty Medical Products Co. for the device "PERFORATED SOAKING TUBE". The FDA issued a decision of Substantially Equivalent on December 2, 1987. The device falls under product code GBQ (Catheter, Continuous Irrigation), a Class I device regulated under 21 CFR 878.4200. Specialty Medical Products Co. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1987
- Date Received
- November 9, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Irrigation
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type