510(k) K242803
K242803 is an FDA 510(k) premarket notification submitted by Medtech Products, Inc. for the device "Compound W Skin Tag Remover". The FDA issued a decision of Substantially Equivalent on November 6, 2024. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Medtech Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2024
- Date Received
- September 17, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type