FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHIRT, MITTEN CUFF INFANT
K Number: K760360
·
Decision Oct 20, 1976
Classifications
1
FEI Numbers
234
Registration Numbers
234
Same Product Code
4
Applicant Total
5
Review Days
79
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Basic Information
- Device Name
- SHIRT, MITTEN CUFF INFANT
- K Number
- K760360
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6265
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Precept, Inc.
- Date Received
- August 2, 1976
- Decision Date
- October 20, 1976
- Product Code
- FME
- 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 |
|---|---|---|---|
| FME | Gown, Examination | FDA class 1 | General Hospital |
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Other Clearances by Precept, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K771409 | DISP. SURGICAL FACE MASK | Oct 27, 1977 | Substantially Equivalent |
| K770463 | MASK, SURGICAL, FACE, DISPOSABLE | Mar 23, 1977 | Substantially Equivalent |
| K770391 | COVER, ARMBOARD, DISPOSABLE | Mar 7, 1977 | Substantially Equivalent |
| K770021 | MASK, FACE, SURGICAL | Jan 17, 1977 | Substantially Equivalent |