POLYKOTE— 510(k) K953299
Substantially EquivalentIntl. Trade Management Co.
FDA 510(k) clearance K953299 for POLYKOTE, Substantially Equivalent on 1995-08-07. Applicant: Intl. Trade Management Co.. Device class: 1.
Clearance details
- Applicant
- Intl. Trade Management Co.
- 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
- Reston, VA, US
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More clearances from Intl. Trade Management Co.
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