FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPRIO-LOOP
K Number: K811419
·
Decision Jun 12, 1981
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
12
Applicant Total
3
Review Days
24
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Basic Information
- Device Name
- SPRIO-LOOP
- K Number
- K811419
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3910
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Datamed, Inc.
- Date Received
- May 19, 1981
- Decision Date
- June 12, 1981
- Product Code
- BTX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| BTX | Board, Arm (With Cover), Sterile | FDA class 1 | General, Plastic Surgery |
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