Nortec Sterile Water for Device Irrigation
FDA 510(k) K925593 · North American Sterilization & Packaging Co.
510(k) numberK925593
Submission
- Device name
- Nortec Sterile Water for Device Irrigation
- Applicant
- North American Sterilization & Packaging Co.
Sparta, NJ, US - Received
- November 5, 1992
- Decision date
- December 3, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
No product code recorded.
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| K981032 | Piv SystemLDQ · Traditional | Medical Solutions, Inc. | 09/02/1998SE |
| K973747 | Controlled Temperature Cabinet SystemLDQ · Traditional | Smith | 05/07/1998SE |
| K955661 | Acu-HaltLDQ · Traditional | Glederer & Co., Inc. | 12/30/1996SE |
| K955776 | Acu-LabLDQ · Traditional | Glederer & Co., Inc. | 06/05/1996SE |
| K945374 | Acu-HaltLDQ · Traditional | Eva-Health USA, Inc. | 08/09/1995SE |
| K944961 | Personal Alarm System (Pas)LDQ · Traditional | Cytoprobe Corp. | 08/07/1995SE |
| K942810 | Palco Labs Cold PouchLDQ · Traditional | Palco Laboratories, Inc. | 06/28/1995SE |
| K930884 | Medical Procedure Tray, ModificationLDQ · Traditional | Enpak Medical Corp. | 03/21/1995SE |
More from Enpak Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K964231 | Nasp Hydrocolloid Dressing (Regular or Thin)KMF · Traditional | 03/10/1997SE |
| K963753 | Nasp Transparent DressingMGP · Traditional | 11/29/1996SE |
| K962352 | Hydrogel Skin DressingNAE · Traditional | 08/02/1996SE |
| K925588 | Nortec Ster SALINE-O.9% Sodium Chlor for Dev IrriLDQ · Traditional | 12/03/1993SE |
| K925161 | Nortec Sterile Water for Catheter Balloon InflatioKNY · Traditional | 07/21/1993SE |
| K911865 | Nortec Connecting Tube SetGAZ · Traditional | 11/01/1991SE |
| K911784 | Nortec Robertazzi Nasopharyngeal AirwayBTQ · Traditional | 09/23/1991SE |
| K910691 | Nortec Ureteral StentFAD · Traditional | 08/15/1991SE |
| K903162 | Flexible Endoscopic ElectrodesFAS · Traditional | 12/18/1990SE |
| K903156 | Control-Tip Cystoscopic ElectrodesFAS · Traditional | 12/18/1990SE |
Questions and answers
When was Nortec Sterile Water for Device Irrigation cleared by the FDA?
Nortec Sterile Water for Device Irrigation (K925593) received a 510(k) decision of Substantially Equivalent on December 3, 1993, 393 days after the submission was received.