OPERATING ROOM SPECIMEN CONTAINER
FDA 510(k) clearance K790291 · decided 1979-04-10
Clearance details
- K-number
- K790291
- Device name
- OPERATING ROOM SPECIMEN CONTAINER
- Applicant
- Sage Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-08
- Decision date
- 1979-04-10
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- FMH
- Device class
- 1
- Regulation number
- 864.3250
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TRI-TECH URINE SPECIMEN KIT (K900983) | Tri-Tech, Inc. | 1990-09-17 |
| VARIOUS-SPECIMEN COLLECTORS (K823763) | Cordis Corp. | 1983-01-19 |
| CALCULI FILTER CUP (K820180) | Omnimedical | 1982-02-05 |
| LANCER SPECIMEN CONTAINER (K812933) | Sherwood Medical Co. | 1981-11-06 |
| SPECIMEN SET (K802340) | American Pharmaseal Div. Ahsc | 1980-10-10 |
| URINE SPECIMEN CONTAINER #'S 1013-1016 (K802002) | Pollak (Intl.), Ltd. | 1980-09-09 |
| MIDSTREAM COLLECTION KIT (K800947) | Sage Products, Inc. | 1980-05-30 |
| SPECIMEN COLLECTION PAN (K800309) | Sage Products, Inc. | 1980-02-26 |
| ABCO MIDSTREAM URINE COLLECTION SET (K800233) | Abco Dealers, Inc. | 1980-02-26 |
| PARA-PAK CLEAN VIAL (K792710) | Meridian Diagnostics, Inc. | 1980-01-28 |
| LANCER SPECIMEN CONTAINER (K792156) | Sherwood Medical Co. | 1979-12-10 |
| SPECIMAN CUP & EMESIS BASIN (K792211) | General Clinical Plastics Corp. | 1979-11-16 |
Recalls involving this device
No recalls on record reference this clearance.