FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHERMEL BONE GOUGES
K Number: K842822
·
Decision Aug 2, 1984
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
5
Applicant Total
7
Review Days
14
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Basic Information
- Device Name
- CHERMEL BONE GOUGES
- K Number
- K842822
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cher Mel Corp.
- Date Received
- July 19, 1984
- Decision Date
- August 2, 1984
- Product Code
- GDH
- 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 |
|---|---|---|---|
| GDH | Gouge, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDH), ordered by most recent decision date.
MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE
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MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
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GOUGES, ALEXANDER, BISHOP, LUCAS
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AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE
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PARKES HUMP GAUGE STRAIGHT 7 (18 CM)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Cher Mel Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K863040 | DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS | Oct 31, 1986 | Substantially Equivalent |
| K851516 | CHERMEL SCALP VEIN SET | Aug 23, 1985 | Substantially Equivalent |
| K842203 | LITTMAN TYPE SH-6010, NURSE TYPE | Jun 6, 1985 | Substantially Equivalent |
| K843324 | SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH | Jun 6, 1985 | Substantially Equivalent |
| K842823 | CHERMEL OSTEOTOMES | Aug 2, 1984 | Substantially Equivalent |
| K842824 | CHERMEL BONE CHISELS | Aug 2, 1984 | Substantially Equivalent |