FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXPANDACELL INJECTO-PAK NASAL PACK
K Number: K960228
·
Decision Feb 27, 1996
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
13
Review Days
41
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Basic Information
- Device Name
- EXPANDACELL INJECTO-PAK NASAL PACK
- K Number
- K960228
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shippert Medical Technologies Corp.
- Date Received
- January 17, 1996
- Decision Date
- February 27, 1996
- 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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Other Clearances by Shippert Medical Technologies Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K102117 | TISSU TRANS FILTRON SYRINGE FILL | Aug 6, 2010 | Substantially Equivalent |
| K092482 | TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 | Dec 4, 2009 | Substantially Equivalent |
| K092022 | TISSU TRANS HARVEST TUBING | Aug 17, 2009 | Substantially Equivalent |
| K050797 | TISSU-TRANS | Jul 13, 2005 | Substantially Equivalent |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | Mar 4, 1997 | Substantially Equivalent |
| K964334 | EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) | Dec 9, 1996 | Substantially Equivalent |
| K963704 | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | Nov 26, 1996 | Substantially Equivalent |
| K962133 | EXPANDACELL INJECTO-PAK | Aug 1, 1996 | Substantially Equivalent |
| K960621 | EXPANDACELL INSTRUMENT WIPE | Apr 1, 1996 | Substantially Equivalent |
| K955593 | EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY | Dec 22, 1995 | Substantially Equivalent |