510(k) K914934
- Device
- HAND PACK
- Applicant
- WESTMARK HOSPITAL SUPPLIES
- 510(k) number
- K914934
- Product code
- KDO
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 1993-01-21
- Date received
- 1991-11-04
- Regulation
- 876.1500
- Classification name
- Rongeur, Cystoscopic, Hot
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- MARJORIE L SCHMIDT
- Address
- 1253 Ramona SE Grand Rapids MI US 49507 49507
Source Documents
510(k) summary PDF not indicated by FDA
Legacy Summary
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FDA Review
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