The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Aspr-care Closed System,dual Swivel Piece T,sheathed Suction Catheter,bronchosope Adapter,in-line Specimen Trap.
| Device ID | K972139 |
| 510k Number | K972139 |
| Device Name: | ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
| Contact | Stephen J Tamsett |
| Correspondent | Stephen J Tamsett DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-06 |
| Decision Date | 1997-09-03 |
| Summary: | summary |