510(k) K782077
- Device
- LANCER ICE CUBE
- Applicant
- SHERWOOD MEDICAL INDUSTRIES
- 510(k) number
- K782077
- Product code
- JRM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-04-03
- Date received
- 1978-12-13
- Regulation
- 862.2050
- Classification name
- Freezer
- Medical specialty
- Clinical Chemistry
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K894006 | SANISERV SURGICAL SLUSH SYSTEM | Saniserv, Inc. | 1989-11-03 |
Legacy Summary#
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FDA Review#
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