FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL LIFT SHEET
K Number: K942807
·
Decision Aug 2, 1994
Classifications
1
FEI Numbers
206
Registration Numbers
207
Same Product Code
12
Applicant Total
23
Review Days
49
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Basic Information
- Device Name
- SURGICAL LIFT SHEET
- K Number
- K942807
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5510
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Surgin Surgical Instrumentation, Inc.
- Date Received
- June 14, 1994
- Decision Date
- August 2, 1994
- Product Code
- FSA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FSA | Lift, Patient, Non-Ac-Powered | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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| K011195 | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB | Nov 6, 2001 | Substantially Equivalent |
| K994015 | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 | Mar 15, 2000 | Substantially Equivalent |
| K980849 | SURGIN KIT | Jul 9, 1998 | Substantially Equivalent |
| K954238 | SURGIN GENISIS HANDPIECE | Dec 8, 1995 | Substantially Equivalent |
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| K942945 | CASSETTE SYSTEM FOR STORZ | Dec 5, 1994 | Substantially Equivalent |
| K942944 | IRRIGATION/BIPOLAR SET | Sep 27, 1994 | Substantially Equivalent |