ATI ETHYLENE OXIDE STERILIZATION INDICATOR— 510(k) K952995
Substantially EquivalentPymah Corp.
FDA 510(k) clearance K952995 for ATI ETHYLENE OXIDE STERILIZATION INDICATOR, Substantially Equivalent on 1996-02-22. Applicant: Pymah Corp.. Device class: 2.
Clearance details
- Applicant
- Pymah Corp.
- Product code
- Product code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flemington, NJ, US
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