POLI-MAK MODEL F-4 (FINAL— 510(k) K820748
Substantially EquivalentPm America, Inc.
FDA 510(k) clearance K820748 for POLI-MAK MODEL F-4 (FINAL, Substantially Equivalent on 1982-04-06. Applicant: Pm America, Inc.. Device class: 1.
Clearance details
- Applicant
- Pm America, Inc.
- Product code
- Code JJF
- Device class
- Class 1
- Regulation
- 21 CFR 862.2170
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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