The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Endoscopes,10mm Diameter 0 Degrees; Endoscopes, 10mm Diameter, 30 Degrees; Endoscopes, 10mm Diameter, 50 Degrees.
| Device ID | K993103 |
| 510k Number | K993103 |
| Device Name: | ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES |
| Classification | Endoscope, Rigid |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Robert L Casara |
| Correspondent | Robert L Casara RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | GCM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-16 |
| Decision Date | 1999-12-10 |
| Summary: | summary |