510(k) K781127
K781127 is an FDA 510(k) premarket notification submitted by Seamless Hospital Products Co. for the device "CONNECTING TUBE, CONDUCTIVE, SURG.". The FDA issued a decision of Substantially Equivalent on September 20, 1978. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Seamless Hospital Products Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1978
- Date Received
- July 5, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Noninvasive
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type