FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KENTRON'S ISOLATION GOWN
K Number: K971917
·
Decision Sep 19, 1997
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
67
Applicant Total
6
Review Days
119
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Basic Information
- Device Name
- KENTRON'S ISOLATION GOWN
- K Number
- K971917
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kentron Health Care, Inc.
- Date Received
- May 23, 1997
- Decision Date
- September 19, 1997
- Product Code
- FYC
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FYC | Gown, Isolation, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Kentron Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030693 | KENTEX DISPOSABLE VAGINAL SPECULUM | Aug 27, 2003 | Substantially Equivalent |
| K972410 | IMPERVIOUS ISOLATION GOWN | Sep 19, 1997 | Substantially Equivalent |
| K953465 | KENTEMP | Dec 15, 1995 | Substantially Equivalent |
| K953914 | KENTEX | Nov 6, 1995 | Substantially Equivalent |
| K953830 | KENSORB | Oct 3, 1995 | Substantially Equivalent |