FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EPISTAXIS NASAL PACK
K Number: K971000
·
Decision May 14, 1997
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
16
Review Days
56
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Basic Information
- Device Name
- EPISTAXIS NASAL PACK
- K Number
- K971000
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Invotec International, Inc.
- Date Received
- March 19, 1997
- Decision Date
- May 14, 1997
- Product Code
- EMX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
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| K930114 | TRACHEOSTOMY T-TUBE | Mar 19, 1993 | Substantially Equivalent |
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| K911040 | INVOTEC MICROSCOPE DRAPE | Jun 3, 1991 | Substantially Equivalent |
| K911039 | INVOTEC EAR DRAPE | May 13, 1991 | Substantially Equivalent |
| K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY | Oct 31, 1990 | Substantially Equivalent |