FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROTEK PROBE DRAPE
K Number: K882724
·
Decision Aug 3, 1988
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
13
Review Days
33
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Basic Information
- Device Name
- MICROTEK PROBE DRAPE
- K Number
- K882724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Microbio-Medics, Inc.
- Date Received
- July 1, 1988
- Decision Date
- August 3, 1988
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | 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 |
| K910167 | MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM | Apr 15, 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 |