ERGO II, SURGICAL LATEX GLOVES— 510(k) K884030
Substantially EquivalentErgo Intl., Ent., Inc.
FDA 510(k) clearance K884030 for ERGO II, SURGICAL LATEX GLOVES, Substantially Equivalent on 1988-11-07. Applicant: Ergo Intl., Ent., Inc.. Device class: 1.
Clearance details
- Applicant
- Ergo Intl., Ent., Inc.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- 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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