FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BANDAGES, SPEC. X-TRA HARD OR PLASTER
K Number: K770929
·
Decision Jun 2, 1977
Classifications
1
FEI Numbers
239
Registration Numbers
239
Same Product Code
36
Applicant Total
206
Review Days
10
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Basic Information
- Device Name
- BANDAGES, SPEC. X-TRA HARD OR PLASTER
- K Number
- K770929
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- May 23, 1977
- Decision Date
- June 2, 1977
- Product Code
- ITG
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ITG | Bandage, Cast | FDA class 1 | Physical Medicine |
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