FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE SURGICAL DRAPES AND ACCESSORIES
K Number: K861531
·
Decision May 23, 1986
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
6
Review Days
29
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Basic Information
- Device Name
- DISPOSABLE SURGICAL DRAPES AND ACCESSORIES
- K Number
- K861531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medical Concepts Development, Inc.
- Date Received
- April 24, 1986
- Decision Date
- May 23, 1986
- 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 Medical Concepts Development, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020581 | COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 | Sep 18, 2002 | Substantially Equivalent |
| K000442 | ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX | Apr 24, 2001 | Substantially Equivalent |
| K924794 | TRANSPARENT ADHESIVE DRESSING | Jul 8, 1993 | Substantially Equivalent |
| K870044 | MCD SPECIALTY BRAND NEEDLE COUNTERS | Jan 21, 1987 | Substantially Equivalent |
| K861530 | SURGICAL PACKS, KITS AND TRAYS | May 30, 1986 | Unknown |