FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELAN-E DISPOSALBE DRAPE
K Number: K882494
·
Decision Jul 8, 1988
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
8
Review Days
22
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Basic Information
- Device Name
- ELAN-E DISPOSALBE DRAPE
- K Number
- K882494
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Dermacare Products, Inc.
- Date Received
- June 16, 1988
- Decision Date
- July 8, 1988
- Product Code
- KKX
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Dermacare Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882421 | INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE | Jun 30, 1988 | Substantially Equivalent |
| K871910 | SURGITEK DISPOSABLE BIPOLAR CORD | Jun 1, 1987 | Substantially Equivalent |
| K863279 | SURGI-TEK TUBE POSITIONER | Sep 9, 1986 | Substantially Equivalent |
| K863280 | DERMAMARKER | Sep 9, 1986 | Substantially Equivalent |
| K863278 | SURGI-WIPES | Sep 2, 1986 | Substantially Equivalent |
| K862367 | PRO-CLEAN | Jul 8, 1986 | Substantially Equivalent |
| K853374 | CORRECT-A-COUNT | Sep 5, 1985 | Substantially Equivalent |