FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SH-1 SURGICAL HOLDER FOR TELESCOPE
K Number: K960068
·
Decision May 5, 1997
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
9
Applicant Total
149
Review Days
486
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Basic Information
- Device Name
- SH-1 SURGICAL HOLDER FOR TELESCOPE
- K Number
- K960068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus America, Inc.
- Date Received
- January 5, 1996
- Decision Date
- May 5, 1997
- Product Code
- OCV
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCV | Endoscope Holder | FDA class 2 | Gastroenterology, Urology |
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