The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fc-38lx, Fiber Colonoscope.
Device ID | K951578 |
510k Number | K951578 |
Device Name: | FC-38LX, FIBER COLONOSCOPE |
Classification | Colonoscope And Accessories, Flexible/rigid |
Applicant | PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
Contact | Paul Silva |
Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
Product Code | FDF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-04 |
Decision Date | 1995-06-27 |