FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE FILTERED INSUFFLATION TUBING SET
K Number: K941685
·
Decision May 26, 1994
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
174
Applicant Total
3
Review Days
50
Basic Information
- Device Name
- DISPOSABLE FILTERED INSUFFLATION TUBING SET
- K Number
- K941685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BLUE PLANET INDUSTRIES, INC.
- Date Received
- April 6, 1994
- Decision Date
- May 26, 1994
- Product Code
- HIF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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