POLYPET— 510(k) K860617
Substantially EquivalentInstrumed, Inc.
FDA 510(k) clearance K860617 for POLYPET, Substantially Equivalent on 1986-03-03. Applicant: Instrumed, Inc.. Device class: 1.
Clearance details
- Applicant
- Instrumed, Inc.
- Product code
- Code JTC
- Device class
- Class 1
- Regulation
- 21 CFR 866.2500
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Union Bridge, MD, US
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