FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
K Number: K920706
·
Decision May 26, 1993
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
6
Applicant Total
1
Review Days
463
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Basic Information
- Device Name
- MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
- K Number
- K920706
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Retrax
- Date Received
- February 18, 1992
- Decision Date
- May 26, 1993
- Product Code
- FHQ
- 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 |
|---|---|---|---|
| FHQ | Holder, Needle, Gastroenterologic | FDA class 1 | Gastroenterology, Urology |
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