The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Badgwell Sampling Catheter.
| Device ID | K870858 |
| 510k Number | K870858 |
| Device Name: | BADGWELL SAMPLING CATHETER |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis, IN 46236 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis, IN 46236 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-05-14 |