PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.)— 510(k) K892100
Substantially EquivalentErgo Intl., Ent., Inc.
FDA 510(k) clearance K892100 for PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.), 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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