510(k) K120532
- Device
- GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
- Applicant
- GETINGE SOURCING LLC
- 510(k) number
- K120532
- Product code
- PEC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-02
- Date received
- 2012-02-22
- Regulation
- 880.6880
- Classification name
- Sterilizer Automated Loading System
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARB SMITH
- Address
- 1777 E. Henrietta Rd. Rochester NY US 14623 14623
FDA Registration Numbers#
- 3005899764
- 3013300766
- 9680353
Source Documents#
Legacy Summary#
summary
FDA Review#
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