FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL INSTRUMENTS
K Number: K881937
·
Decision Jun 15, 1988
Classifications
1
FEI Numbers
182
Registration Numbers
182
Same Product Code
14
Applicant Total
2
Review Days
37
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Basic Information
- Device Name
- SURGICAL INSTRUMENTS
- K Number
- K881937
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Far East Intl. Trading Corp.
- Date Received
- May 9, 1988
- Decision Date
- June 15, 1988
- Product Code
- HRQ
- 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 |
|---|---|---|---|
| HRQ | Hemostat | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRQ), ordered by most recent decision date.
DISPOSABLE HEMOSTATS
FDA 510(k)
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BERNARD VESSEL APPROXIMATOR
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SURGICAL HEMOSTATS
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FDA Class 1
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SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)
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MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEMSTATS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Far East Intl. Trading Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K881638 | SURGICAL BLADE | Jun 15, 1988 | Substantially Equivalent |