The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Medical/surgical Suction System.
| Device ID | K851384 |
| 510k Number | K851384 |
| Device Name: | MEDICAL/SURGICAL SUCTION SYSTEM |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Contact | Hartely C Ericson |
| Correspondent | Hartely C Ericson PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-05-08 |