Compound W Wart Removal System Dual Power
FDA 510(k) K161294 · Medtech Products, Inc.
510(k) numberK161294
Submission
- Device name
- Compound W Wart Removal System Dual Power
- Applicant
- Medtech Products, Inc.
Tarrytown, NY, US - Received
- May 9, 2016
- Decision date
- September 15, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Compound W Wart Removal System Dual Power cleared by the FDA?
Compound W Wart Removal System Dual Power (K161294) received a 510(k) decision of Substantially Equivalent on September 15, 2016, 129 days after the submission was received.
What is the product code of K161294?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.