FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEGA ARTHROGRAM KIT
K Number: K913317
·
Decision Oct 31, 1991
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
7
Review Days
98
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Basic Information
- Device Name
- MEGA ARTHROGRAM KIT
- K Number
- K913317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mega Medical, Inc.
- Date Received
- July 25, 1991
- Decision Date
- October 31, 1991
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Mega Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915863 | MEGA AMNIOCENTESIS KIT | Mar 30, 1992 | Unknown |
| K913397 | MEGA ANGIOGRAM KIT | Oct 31, 1991 | Unknown |
| K912445 | MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT | Oct 18, 1991 | Substantially Equivalent |
| K913382 | MEGA PARACENTESIS KIT | Oct 8, 1991 | Substantially Equivalent |
| K912322 | MEGA SPINAL ANESTHESIA KIT | Sep 26, 1991 | Unknown |
| K912564 | MEGA PERICARDIOCENTESIS KIT | Sep 5, 1991 | Substantially Equivalent |