FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS
K Number: K881276
·
Decision May 4, 1988
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
42
Applicant Total
2
Review Days
40
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Basic Information
- Device Name
- HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS
- K Number
- K881276
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ime Co. , Ltd.
- Date Received
- March 25, 1988
- Decision Date
- May 4, 1988
- Product Code
- KCW
- 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 |
|---|---|---|---|
| KCW | Epilator, High Frequency, Needle-Type | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCW), ordered by most recent decision date.
COMPU-BLEND EPILATOR
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STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION
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HAIR REMOVAL SYSTEM
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THE SS-99
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FDA 510(k)
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Other Clearances by Ime Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K864869 | HR-5000 ELECTROSURGICAL DEVICE | May 19, 1987 | Substantially Equivalent |