FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZEE SURGICAL INSTRUMENTS
K Number: K812814
·
Decision Nov 6, 1981
Classifications
1
FEI Numbers
430
Registration Numbers
430
Same Product Code
15
Applicant Total
8
Review Days
31
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Basic Information
- Device Name
- ZEE SURGICAL INSTRUMENTS
- K Number
- K812814
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Zee Medical Products Co., Inc.
- Date Received
- October 6, 1981
- Decision Date
- November 6, 1981
- Product Code
- GDZ
- 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 |
|---|---|---|---|
| GDZ | Handle, Scalpel | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDZ), ordered by most recent decision date.
SPECTRA MEDICAL SAFETY SCAPEL
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SCALPEL HANDLE
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BEAVER(R) HANDLE
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P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE
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THE S. CORDERO STYLUS
FDA 510(k)
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·General, Plastic Surgery
KEISEI HANDLES FOR SURGICAL BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Zee Medical Products Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823501 | ZEE SPHYGMOMANOMETER | Jan 21, 1983 | Substantially Equivalent |
| K813156 | ULTRA-WIDE SAFETY SPECTACLE FRAME | Dec 14, 1981 | Substantially Equivalent |
| K813016 | ZEE TRACTION SPLINT | Nov 24, 1981 | Substantially Equivalent |
| K812564 | ZEE LIFE SUPPORT AIR PANTS | Oct 23, 1981 | Substantially Equivalent |
| K812342 | ZEE EXTRICATION DEVICE | Sep 21, 1981 | Substantially Equivalent |
| K812284 | ZEE ELECTRODE-GEL | Sep 8, 1981 | Substantially Equivalent |
| K812022 | ZEE MANUAL RESUSCITATOR | Jul 31, 1981 | Substantially Equivalent |