FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS
K Number: K863040
·
Decision Oct 31, 1986
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
7
Review Days
80
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Basic Information
- Device Name
- DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS
- K Number
- K863040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Cher Mel Corp.
- Date Received
- August 12, 1986
- Decision Date
- October 31, 1986
- Product Code
- KPE
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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Other Clearances by Cher Mel Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K851516 | CHERMEL SCALP VEIN SET | Aug 23, 1985 | Substantially Equivalent |
| K842203 | LITTMAN TYPE SH-6010, NURSE TYPE | Jun 6, 1985 | Substantially Equivalent |
| K843324 | SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH | Jun 6, 1985 | Substantially Equivalent |
| K842822 | CHERMEL BONE GOUGES | Aug 2, 1984 | Substantially Equivalent |
| K842823 | CHERMEL OSTEOTOMES | Aug 2, 1984 | Substantially Equivalent |
| K842824 | CHERMEL BONE CHISELS | Aug 2, 1984 | Substantially Equivalent |