510(k) K872157
K872157 is an FDA 510(k) premarket notification submitted by Solco Basle, Inc. for the device "HALL VEIN STRIPPER". The FDA issued a decision of Substantially Equivalent on July 7, 1987. The device falls under product code DWQ (Stripper, Vein, External), a Class II device regulated under 21 CFR 870.4885. Solco Basle, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 1987
- Date Received
- June 4, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stripper, Vein, External
- Device Class
- Class II
- Regulation Number
- 870.4885
- Review Panel
- CV
- Submission Type