The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Laparoscopic Cleaning Brush Instrument.
| Device ID | K911481 |
| 510k Number | K911481 |
| Device Name: | LAPAROSCOPIC CLEANING BRUSH INSTRUMENT |
| Classification | Endoscopic Cytology Brush |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Contact | Dean Secrest |
| Correspondent | Dean Secrest UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-04 |
| Decision Date | 1991-04-22 |