510(k) K962032
- Device
- KARL STORZ TWIN TRANSILLUMINATOR
- Applicant
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- 510(k) number
- K962032
- Product code
- MQW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-05
- Date received
- 1996-05-24
- Regulation
- 874.4350
- Classification name
- Transilluminator, Fiber Optic
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARIKA ANDERSON
- Address
- 600 Corporate Pt.e Culver City CA US 90230 90230
FDA Registration Numbers#
- 3013247477
- 3015718821
- 8030607
- 1720747
- 3010202439
- 1836161
- 1221826
- 2020550
- 3010726901
- 9610773
- 3011050570
- 3014342096
Source Documents#
Legacy Summary#
summary
FDA Review#
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