510(k) K922110
- Device
- GO-CLEAN
- Applicant
- VIVA-TEK ASSOC., INC.
- 510(k) number
- K922110
- Product code
- FRR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-09
- Date received
- 1992-05-05
- Regulation
- 880.5450
- Classification name
- Chamber, Reverse Isolation, Patient Care
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- RONALD D RICCIUTI
- Address
- 82 Chairville Rd. Medford NJ US 08055 08055
Source Documents
510(k) summary PDF not indicated by FDA
Legacy Summary
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FDA Review
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