510(k) K780261
- Device
- COVERSLIPPER
- Applicant
- SHANDON, INC.
- 510(k) number
- K780261
- Product code
- KIM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-18
- Date received
- 1978-02-16
- Regulation
- 864.3400
- Classification name
- Device For Sealing Microsections
- Medical specialty
- Pathology
- Review panel
- Hematology
- 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#
- 1063851
- 2083544
- 3015167933
- 3004775917
- 1000303355
- 3010889707
- 8010478
- 9680927
- 3003584784
- 3043606682
- 3008399755
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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