PATIENT EXAM GLOVES (MFG. SHUN TAHI RUBBER GLOVES)— 510(k) K892101
Substantially EquivalentErgo Intl., Ent., Inc.
FDA 510(k) clearance K892101 for PATIENT EXAM GLOVES (MFG. SHUN TAHI RUBBER GLOVES), Substantially Equivalent on 1989-05-08. Applicant: Ergo Intl., Ent., Inc.. Device class: 1.
Clearance details
- Applicant
- Ergo Intl., Ent., Inc.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Miami Beach, FL, US
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More clearances from Ergo Intl., Ent., Inc.
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