The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact 901 Series Port-a-wall.
| Device ID | K850671 |
| 510k Number | K850671 |
| Device Name: | IMPACT 901 SERIES PORT-A-WALL |
| Classification | Stand, Infusion |
| Applicant | IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota, NJ 07603 |
| Contact | Leslie H Sherman |
| Correspondent | Leslie H Sherman IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota, NJ 07603 |
| Product Code | FOX |
| CFR Regulation Number | 880.6990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-20 |
| Decision Date | 1985-03-11 |