FDA 510(k)
Substantially Equivalent
🇺🇸 United States
NORTEC STERILE WATER FOR DEVICE IRRIGATION
K Number: K925593
·
Decision Dec 3, 1993
Classifications
0
FEI Numbers
10
Registration Numbers
10
Same Product Code
80
Applicant Total
16
Review Days
393
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Basic Information
- Device Name
- NORTEC STERILE WATER FOR DEVICE IRRIGATION
- K Number
- K925593
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- North American Sterilization & Packaging Co.
- Date Received
- November 5, 1992
- Decision Date
- December 3, 1993
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDQ), ordered by most recent decision date.
Other Clearances by North American Sterilization & Packaging Co.
| K Number | Device Name | ||
|---|---|---|---|
| K964231 | NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) | Mar 10, 1997 | Substantially Equivalent |
| K963753 | NASP TRANSPARENT DRESSING | Nov 29, 1996 | Substantially Equivalent |
| K962352 | HYDROGEL SKIN DRESSING | Aug 2, 1996 | Substantially Equivalent |
| K925588 | NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI | Dec 3, 1993 | Substantially Equivalent |
| K925161 | NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO | Jul 21, 1993 | Substantially Equivalent |
| K911865 | NORTEC CONNECTING TUBE SET | Nov 1, 1991 | Substantially Equivalent |
| K911784 | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | Sep 23, 1991 | Substantially Equivalent |
| K910691 | NORTEC URETERAL STENT | Aug 15, 1991 | Substantially Equivalent |
| K903162 | FLEXIBLE ENDOSCOPIC ELECTRODES | Dec 18, 1990 | Substantially Equivalent |
| K903156 | CONTROL-TIP CYSTOSCOPIC ELECTRODES | Dec 18, 1990 | Substantially Equivalent |