FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TISSU TRANS HARVEST TUBING
K Number: K092022
·
Decision Aug 17, 2009
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
13
Review Days
42
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Basic Information
- Device Name
- TISSU TRANS HARVEST TUBING
- K Number
- K092022
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shippert Medical Technologies Corp.
- Date Received
- July 6, 2009
- Decision Date
- August 17, 2009
- Product Code
- KYZ
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
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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 |
| 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 |
| K960228 | EXPANDACELL INJECTO-PAK NASAL PACK | Feb 27, 1996 | Substantially Equivalent |
| K955593 | EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY | Dec 22, 1995 | Substantially Equivalent |