510(k) K081879
- Device
- SPSMEDICAL SPORVIEW PA CULTURE SET
- Applicant
- SPS MEDICAL SUPPLY CORP.
- 510(k) number
- K081879
- Product code
- MRB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-30
- Date received
- 2008-07-02
- Regulation
- 880.2800
- Classification name
- Indicator, Biological, Liquid Chemical Sterilization Process
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY J SOCOLA
- 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 |
|---|---|---|---|
| K053212 | RAVEN PROPACT | Raven Biological Laboratories, Inc. | 2006-02-15 |
| K043135 | SPSMEDICAL SPORVIEW PA CULTURE SET | Spsmedical Supply Corp. | 2005-01-13 |
| K031114 | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | Raven Biological Laboratories, Inc. | 2004-03-03 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases