510(k) K894006
- Device
- Saniserv Surgical Slush System
- Applicant
- SANISERV, INC.
- 510(k) number
- K894006
- Product code
- JRM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-11-03
- Date received
- 1989-06-05
- Regulation
- 862.2050
- Classification name
- Freezer
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK FARLEY
- Address
- P.O. Box 41240 2020 Production Dr. Indianapolis IN US 46241 46241
FDA Registration Numbers#
- 3017858437
- 3031700059
- 3014325803
- 1523845
- 3012315023
- 3001246104
- 3018228712
- 3019916040
- 1036832
- 1526542
- 3030063003
- 3017637606
- 1058584
- 3012858319
- 3013659199
- 3014739961
- 3003244268
- 3007127121
- 3004973569
- 3038620105
- 3005853119
- 3018783057
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JRM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921568 | ORS-100 | Mnlase, Inc. | 1992-06-09 |
| K921569 | ORS-200 | Mnlase, Inc. | 1992-06-09 |
| K921570 | ORS-300 | Mnlase, Inc. | 1992-06-09 |
| K915427 | ORS-1000 | Mnlase, Inc. | 1992-01-07 |
| K913777 | SELF-CONTAINED SURGICAL SLUSH FREEZER | Taylor Corp. | 1991-09-25 |
| K782077 | LANCER ICE CUBE | Sherwood Medical Industries | 1979-04-03 |