FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INVOTEC EAR DRAPE
K Number: K911039
·
Decision May 13, 1991
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
16
Review Days
66
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Basic Information
- Device Name
- INVOTEC EAR DRAPE
- K Number
- K911039
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Invotec International, Inc.
- Date Received
- March 8, 1991
- Decision Date
- May 13, 1991
- 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 Invotec International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Oct 31, 2013 | Substantially Equivalent |
| K080740 | CLEARVIEW ENDOSCOPE COVER | Dec 31, 2008 | Substantially Equivalent |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | Mar 3, 2003 | Substantially Equivalent |
| K973580 | INVOTEC CLEAN PAD | Dec 10, 1997 | Substantially Equivalent |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | Nov 6, 1997 | Substantially Equivalent |
| K971000 | EPISTAXIS NASAL PACK | May 14, 1997 | Substantially Equivalent |
| K930114 | TRACHEOSTOMY T-TUBE | Mar 19, 1993 | Substantially Equivalent |
| K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE | Jun 4, 1991 | Substantially Equivalent |
| K911040 | INVOTEC MICROSCOPE DRAPE | Jun 3, 1991 | Substantially Equivalent |
| K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY | Oct 31, 1990 | Substantially Equivalent |