FDA 510(k)
Substantially Equivalent
🇺🇸 United States
STERI-GRIP
K Number: K853507
·
Decision Sep 5, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
15
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Basic Information
- Device Name
- STERI-GRIP
- K Number
- K853507
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Clinical Technology Corp.
- Date Received
- August 21, 1985
- Decision Date
- September 5, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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|---|---|---|---|
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| K872705 | BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) | Sep 1, 1987 | Substantially Equivalent |
| K855138 | BOVIE ULTRASONIC SURGICAL SYSTEM | Nov 10, 1986 | Substantially Equivalent |
| K854231 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES | May 2, 1986 | Substantially Equivalent |
| K852986 | GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN | Aug 19, 1985 | Substantially Equivalent |
| K844565 | BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) | Feb 21, 1985 | Substantially Equivalent |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Apr 13, 1984 | Substantially Equivalent |
| K823077 | URINARY BLADDER TEMP. SENSOR #81-003 | Mar 9, 1983 | Substantially Equivalent |