FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
K Number: K850133
·
Decision Feb 28, 1985
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
15
Review Days
45
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Basic Information
- Device Name
- VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
- K Number
- K850133
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Consolidated Medical Equipment, Inc.
- Date Received
- January 14, 1985
- Decision Date
- February 28, 1985
- Product Code
- KGX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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ADHESIVE BANDAGES WITH OTC DRUG
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TARGETT PATCH
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PARALLEL
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Other Clearances by Consolidated Medical Equipment, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854040 | I.V. DRESSING | Jan 9, 1986 | Substantially Equivalent |
| K850132 | DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC | Apr 9, 1985 | Substantially Equivalent |
| K850130 | PRN ECG ELECTRODE | Apr 9, 1985 | Substantially Equivalent |
| K850037 | CLOSED WOUND DRAIN | Mar 19, 1985 | Substantially Equivalent |
| K844942 | PLURA-GARD CHEST DRAINAGE SYSTEM | Mar 12, 1985 | Substantially Equivalent |
| K850311 | DISPOS. CONDUCTIVE ADHESIVE TENS PAD | Mar 5, 1985 | Substantially Equivalent |
| K850131 | CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS | Mar 5, 1985 | Substantially Equivalent |
| K850129 | MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN | Feb 28, 1985 | Substantially Equivalent |
| K844372 | HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE | Feb 21, 1985 | Substantially Equivalent |
| K844371 | HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE | Feb 20, 1985 | Substantially Equivalent |