510(k) K954982
- Device
- KSEA SCALP BLOOD COLLECTION SET
- Applicant
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- 510(k) number
- K954982
- Product code
- HGK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-17
- Date received
- 1995-10-31
- Regulation
- 884.1660
- Classification name
- Endoscope, Fetal Blood Sampling (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- 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#
- 3010707607
- 3010202439
- 9610617
- 2020550
- 3014342096
Source Documents#
Legacy Summary#
summary
FDA Review#
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