FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇦 Canada
SONOCA ULTRASONIC SURGICAL SYSTEM
K Number: K893926
·
Decision Nov 14, 1989
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
6
Review Days
167
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Basic Information
- Device Name
- SONOCA ULTRASONIC SURGICAL SYSTEM
- K Number
- K893926
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Holl Meditronics, Inc.
- Date Received
- May 31, 1989
- Decision Date
- November 14, 1989
- Product Code
- LFL
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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Other Clearances by Holl Meditronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954171 | ARCO-MBC, ARCO MC | Apr 30, 1996 | Substantially Equivalent |
| K942095 | SONOCA III | Nov 9, 1994 | Substantially Equivalent |
| K911600 | ILCO INFRARED LIGHT COAGULATOR | Jul 9, 1991 | Substantially Equivalent |
| K893924 | MOTO-MED RF-II AND PICO | Nov 27, 1990 | Substantially Equivalent |
| K901737 | SONOCA II ULTRASONIC SURGICAL DEVICE | Jul 3, 1990 | Substantially Equivalent |