510(k) K950308
- Device
- STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
- Applicant
- SOLARCARE TECHNOLOGIES CORP,INC.
- 510(k) number
- K950308
- Product code
- JXS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-14
- Date received
- 1995-01-25
- Regulation
- 874.3540
- Classification name
- Block, Cutting, Ent, Sterile
- Medical specialty
- Ear Nose & Throat
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- R. SAM NIEDBALA
- Address
- 1745 Eaton Ave. Bethlehem PA US 18018 18018
FDA Registration Numbers#
- 1058726
- 8030607
- 3010303097
- 1313525
- 3006017180
- 1836161
- 9610905
- 8040263
- 3036795921
- 3010041511
- 1928237
- 3010097171
- 1057946
- 1932180
- 3012185136
- 3011137372
- 3031231776
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JXS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822371 | MICRO WORKTABLE | Treace Medical, Inc. | 1982-09-09 |
Legacy Summary#
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FDA Review#
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