510(k) K883514
- Device
- EXAKT CUTTING & GRINDING SYSTEM
- Applicant
- EXAKT MEDICAL INSTRUMENTS, INC.
- 510(k) number
- K883514
- Product code
- IDP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-08-29
- Date received
- 1988-08-17
- Regulation
- 864.3010
- Classification name
- Microtome, Cryostat
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LINDA E DURBIN
- Address
- 1000 S. Mckinley P.O.Box 83343 Oklahoma City OK US 73148 73148
FDA Registration Numbers#
- 3004594181
- 3021013124
- 9615162
- 3027645317
- 3043606682
- 3043088937
- 3005642384
- 8010478
- 1000391282
- 3043138885
- 3038188821
- 3010781643
- 3003584784
- 1063851
- 3010889707
- 2083544
- 3008399755
- 3015167933
- 3014680809
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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