FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLOSED WOUND DRAIN
K Number: K850037
·
Decision Mar 19, 1985
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
15
Review Days
71
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Basic Information
- Device Name
- CLOSED WOUND DRAIN
- K Number
- K850037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Consolidated Medical Equipment, Inc.
- Date Received
- January 7, 1985
- Decision Date
- March 19, 1985
- Product Code
- GCY
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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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 |
| 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 |
| K850133 | VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. | 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 |