510(k) K020126
- Device
- MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)
- Applicant
- SURX, INC.
- 510(k) number
- K020126
- Product code
- MUK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-03-15
- Date received
- 2002-01-15
- Regulation
- 878.4400
- Classification name
- Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAN CURTIS
- Address
- 2675 Collier Canyon Rd. Livermore CA US 94550 94550
Source Documents#
Other 510(k) Records For Product Code MUK #
Legacy Summary#
summary
FDA Review#
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