FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
100% COTTON ABSORBENT TOWEL
K Number: K860248
·
Decision Feb 19, 1986
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
47
Review Days
26
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Basic Information
- Device Name
- 100% COTTON ABSORBENT TOWEL
- K Number
- K860248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Devon Industries, Inc.
- Date Received
- January 24, 1986
- Decision Date
- February 19, 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 Devon Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961993 | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) | Jul 3, 1996 | Substantially Equivalent |
| K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | Nov 20, 1995 | Substantially Equivalent |
| K946289 | DEVONS POINT LOK NEEDLE PROTECTION DEVICE | Jul 10, 1995 | Substantially Equivalent |
| K945197 | THE SHARPS COLLECTION AND DISPOSAL SYSTEM | Dec 2, 1994 | Substantially Equivalent |
| K943892 | POINT OF USE SHARPS A GATOR | Dec 2, 1994 | Substantially Equivalent |
| K944114 | PHLEBOTOMY UNIT SHARPS A GATOR | Dec 2, 1994 | Substantially Equivalent |
| K945485 | ABG NEEDLE PROTECTION | Nov 29, 1994 | Substantially Equivalent |
| K932998 | EASY-ON | Aug 18, 1993 | Substantially Equivalent |
| K912824 | DEVON SPONGE COUNTER BAGS | Aug 26, 1991 | Substantially Equivalent |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | Sep 7, 1989 | Substantially Equivalent |