510(k) K971328
- Device
- OLYMPUS CD-6C-1 COAGULATION ELECTRODE
- Applicant
- OLYMPUS AMERICA, INC.
- 510(k) number
- K971328
- Product code
- FFE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-01
- Date received
- 1997-04-10
- Regulation
- 876.4650
- Classification name
- System, Water Jet Catheter, Renal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUBHASH R PATEL
- Address
- Two Corporate Center Dr. Melville NY US 11747 11747
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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