510(k) K811726
- Device
- LEKSELL STEREOACTIC SYSTEM
- Applicant
- DOWNS SURGICAL LTD.
- 510(k) number
- K811726
- Product code
- LHF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-10
- Date received
- 1981-06-18
- Regulation
- 880.5725
- Classification name
- Warmer, Microwave, Infusion Fluid
- Medical specialty
- General Hospital
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K811724 | 2M 9810 MICROWAVE OVEN | Travenol Laboratories, S.A. | 1981-07-10 |
Legacy Summary#
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FDA Review#
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