FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KOLOR KODE TM
K Number: K821166
·
Decision May 13, 1982
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
47
Review Days
17
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- KOLOR KODE TM
- K Number
- K821166
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Devon Industries, Inc.
- Date Received
- April 26, 1982
- Decision Date
- May 13, 1982
- Product Code
- KDC
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDC), ordered by most recent decision date.
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THERMUFF BAG
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANUAL SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE CAUTERY ABRASIVE PAD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSTRUMENT ORGANIZER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |