SPECULITE— 510(k) K963391
Substantially EquivalentTrylon Corp.
FDA 510(k) clearance K963391 for SPECULITE, Substantially Equivalent on 1997-12-12. Applicant: Trylon Corp.. Device class: 2.
Clearance details
- Applicant
- Trylon Corp.
- Product code
- Code MPU
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monarch Beach, CA, US
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