FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
I.M. RETROGRADE BLADES
K Number: K810045
·
Decision Feb 12, 1981
Classifications
1
FEI Numbers
304
Registration Numbers
304
Same Product Code
26
Applicant Total
26
Review Days
35
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Basic Information
- Device Name
- I.M. RETROGRADE BLADES
- K Number
- K810045
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Hogan & Hartson
- Date Received
- January 8, 1981
- Decision Date
- February 12, 1981
- Product Code
- GFA
- 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 |
|---|---|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | FDA class 1 | General, Plastic Surgery |
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| K973849 | BIOABSORBABLE BANKART TACK | Jan 6, 1998 | Substantially Equivalent |
| K973162 | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | Nov 20, 1997 | Substantially Equivalent |
| K950169 | RIBOSOMAL P EIA TEST SYSTEM | May 23, 1996 | Substantially Equivalent |
| K942389 | TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | Feb 16, 1996 | Substantially Equivalent |
| K946217 | CARDIOLIPIN M EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946216 | CARDIOLIPIN A EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946215 | CARDIOLIPIN G EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946186 | CHAL-2500 | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K941566 | COMPUSPEAK | Jun 30, 1995 | Substantially Equivalent |