FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMO-WEDGE
K Number: K790555
·
Decision Jan 17, 1980
Classifications
1
FEI Numbers
371
Registration Numbers
371
Same Product Code
15
Applicant Total
30
Review Days
304
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Basic Information
- Device Name
- HEMO-WEDGE
- K Number
- K790555
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parker Laboratories, Inc.
- Date Received
- March 19, 1979
- Decision Date
- January 17, 1980
- Product Code
- DZN
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZN | Instruments, Dental Hand | FDA class 1 | Dental |
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| K864556 | AQUALUBE(TM) | Dec 1, 1986 | Substantially Equivalent |
| K861239 | ACRYLIC SOLDER | Apr 17, 1986 | Substantially Equivalent |
| K855167 | DYNA SYSTEM | Mar 4, 1986 | Substantially Equivalent |
| K851895 | POLYGEL ULTRASOUND GEL | Sep 27, 1985 | Substantially Equivalent |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | Aug 9, 1985 | Substantially Equivalent |
| K841400 | NEURO PULSE | Jun 15, 1984 | Substantially Equivalent |
| K840548 | RESIL | Apr 17, 1984 | Substantially Equivalent |