PERSONAL CATHETER
Catheter, Urethral
ROCHESTER MEDICAL CORP.
The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for Personal Catheter.
Pre-market Notification Details
| Device ID | K970704 |
| 510k Number | K970704 |
| Device Name: | PERSONAL CATHETER |
| Classification | Catheter, Urethral |
| Applicant | ROCHESTER MEDICAL CORP. 1500 NW 2ND AVE. P.O. BOX 188 Stewartville, MN 55976 |
| Contact | Mary Wilen |
| Correspondent | Mary Wilen ROCHESTER MEDICAL CORP. 1500 NW 2ND AVE. P.O. BOX 188 Stewartville, MN 55976 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-26 |
| Decision Date | 1997-03-13 |
| Summary: | summary |
Trademark Results [PERSONAL CATHETER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERSONAL CATHETER 75284763 2256336 Live/Registered |
Rochester Medical Corporation 1997-05-01 |
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