The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Es-3800, Video Sigmoidoscope.
| Device ID | K951577 |
| 510k Number | K951577 |
| Device Name: | ES-3800, VIDEO SIGMOIDOSCOPE |
| Classification | Sigmoidoscope 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 | FAM |
| 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 | 1996-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333232642 | K951577 | 000 |
| 04961333232635 | K951577 | 000 |
| 04961333228164 | K951577 | 000 |
| 04961333115303 | K951577 | 000 |