The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Cystofiberscope, Model Fcy-15p.
Device ID | K914008 |
510k Number | K914008 |
Device Name: | PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P |
Classification | Cystoscope And Accessories, Flexible/rigid |
Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
Contact | Lorraine Schwartz |
Correspondent | Lorraine Schwartz PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
Product Code | FAJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-09 |
Decision Date | 1992-01-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04961333243419 | K914008 | 000 |
04961333232734 | K914008 | 000 |
04961333232413 | K914008 | 000 |
04961333232406 | K914008 | 000 |
04961333232390 | K914008 | 000 |
04961333228058 | K914008 | 000 |
04961333224951 | K914008 | 000 |
04961333246465 | K914008 | 000 |
04961333084463 | K914008 | 000 |