BLADE, SCALPEL & BLADE, HANDEL— 510(k) K954536
Substantially EquivalentAccess Surgical Intl., Inc.
FDA 510(k) clearance K954536 for BLADE, SCALPEL & BLADE, HANDEL, Substantially Equivalent on 1995-11-29. Applicant: Access Surgical Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Access Surgical Intl., Inc.
- Product code
- Code OCZ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MA, US
Recent devices under product code OCZ
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