GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
FDA 510(k) clearance K120532 · decided 2013-05-02
Clearance details
- K-number
- K120532
- Device name
- GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
- Applicant
- Getinge Sourcing, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-02-22
- Decision date
- 2013-05-02
- Days to decision
- 435 days
- Clearance type
- Traditional
- Product code
- PEC
- Device class
- 2
- Regulation number
- 880.6880
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.