FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
K Number: K910167
·
Decision Apr 15, 1991
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
- K Number
- K910167
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Microbio-Medics, Inc.
- Date Received
- January 15, 1991
- Decision Date
- April 15, 1991
- Product Code
- GCY
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Microbio-Medics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923353 | VENTILATION TUBES W/ HYDROGEL COATING | May 18, 1993 | Substantially Equivalent |
| K922572 | 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR | Nov 2, 1992 | Substantially Equivalent |
| K913276 | MICROTEK MEDICAL'S SOUND STIKS | Oct 21, 1991 | Substantially Equivalent |
| K904239 | SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES | Jun 21, 1991 | Substantially Equivalent |
| K900726 | MICROTEK MEDICAL'S BLOOD COLLECTION KIT | May 4, 1990 | Substantially Equivalent |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Mar 20, 1990 | Substantially Equivalent |
| K895815 | MICROTEK TOTAL OSSICULAR PROTHESIS | Dec 26, 1989 | Substantially Equivalent |
| K895814 | MICROTEK PISTON & WIRE PROSTHESES | Dec 26, 1989 | Substantially Equivalent |
| K895502 | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | Dec 8, 1989 | Substantially Equivalent |
| K885201 | OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT | Apr 19, 1989 | Substantially Equivalent |