The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fe-24x, Fiber Esophagoscope.
Device ID | K951197 |
510k Number | K951197 |
Device Name: | FE-24X, FIBER ESOPHAGOSCOPE |
Classification | Esophagoscope, General & Plastic Surgery |
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 | GCL |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-16 |
Decision Date | 1995-05-30 |