VAN-TEC MEATAL DILATOR
FDA 510(k) clearance K851158 · decided 1985-04-15
Clearance details
- K-number
- K851158
- Device name
- VAN-TEC MEATAL DILATOR
- Applicant
- Van-Tec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-22
- Decision date
- 1985-04-15
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- KOE
- Device class
- 2
- Regulation number
- 876.5520
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.