510(k) K043135
- Device
- SPSMEDICAL SPORVIEW PA CULTURE SET
- Applicant
- SPS MEDICAL SUPPLY CORP.
- 510(k) number
- K043135
- Product code
- MRB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-01-13
- Date received
- 2004-11-12
- Regulation
- 880.2800
- Classification name
- Indicator, Biological, Liquid Chemical Sterilization Process
- 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
- GARY J SCOLA
- Address
- 6789 W. Henrietta Rd. Rush NY US 14543 14543
FDA Registration Numbers#
- 3004080920
Source Documents#
Other 510(k) Records For Product Code MRB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081879 | SPSMEDICAL SPORVIEW PA CULTURE SET | Spsmedical Supply Corp. | 2008-07-30 |
| K053212 | RAVEN PROPACT | Raven Biological Laboratories, Inc. | 2006-02-15 |
| K031114 | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | Raven Biological Laboratories, Inc. | 2004-03-03 |
Legacy Summary#
summary
FDA Review#
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