EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12— 510(k) K944359
Substantially EquivalentRexton, Inc.
FDA 510(k) clearance K944359 for EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12, Substantially Equivalent on 1994-12-29. Applicant: Rexton, Inc.. Device class: 1.
Clearance details
- Applicant
- Rexton, Inc.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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