The following data is part of a premarket notification filed by Apogee Medical, Inc. with the FDA for Closed System Intermittent Catheterization Kit.
| Device ID | K032710 |
| 510k Number | K032710 |
| Device Name: | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT |
| Classification | Catheter, Urological |
| Applicant | APOGEE MEDICAL, INC. 90 WEATHERS ST. Youngsville, NC 27596 |
| Contact | Diane N Peper |
| Correspondent | Diane N Peper APOGEE MEDICAL, INC. 90 WEATHERS ST. Youngsville, NC 27596 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2004-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20610075177480 | K032710 | 000 |
| 20610075177206 | K032710 | 000 |
| 20610075177190 | K032710 | 000 |
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| 20610075177336 | K032710 | 000 |
| 20610075177312 | K032710 | 000 |
| 20610075177305 | K032710 | 000 |
| 20610075177299 | K032710 | 000 |
| 20610075177077 | K032710 | 000 |