The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fe-34th, Fiber Esophagoscope.
| Device ID | K951198 |
| 510k Number | K951198 |
| Device Name: | FE-34TH, 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333227532 | K951198 | 000 |
| 04961333227518 | K951198 | 000 |
| 04961333227495 | K951198 | 000 |
| 04961333227471 | K951198 | 000 |
| 04961333224807 | K951198 | 000 |
| 04961333224784 | K951198 | 000 |
| 04961333224746 | K951198 | 000 |
| 04961333224722 | K951198 | 000 |