The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fnl-10p, Fiber Nasoparhyngoscope.
| Device ID | K951196 |
| 510k Number | K951196 |
| Device Name: | FNL-10P, FIBER NASOPARHYNGOSCOPE |
| Classification | Nasopharyngoscope (flexible Or 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 | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-16 |
| Decision Date | 1995-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333232796 | K951196 | 000 |
| 04961333232772 | K951196 | 000 |
| 04961333232765 | K951196 | 000 |
| 04961333224258 | K951196 | 000 |
| 04961333224234 | K951196 | 000 |
| 04961333224036 | K951196 | 000 |
| 04961333246472 | K951196 | 000 |
| 04961333084562 | K951196 | 000 |