The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Nonrebreathing Circuit.
| Device ID | K882285 |
| 510k Number | K882285 |
| Device Name: | NONREBREATHING CIRCUIT |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-01 |
| Decision Date | 1988-08-16 |