The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Palestrant Irrigation And Drainage Set.
| Device ID | K896087 |
| 510k Number | K896087 |
| Device Name: | PALESTRANT IRRIGATION AND DRAINAGE SET |
| Classification | Accessories, Catheter |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Contact | Robert E Franklin |
| Correspondent | Robert E Franklin NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Product Code | KGZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-19 |
| Decision Date | 1989-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965905000501 | K896087 | 000 |
| 20193489068242 | K896087 | 000 |