The following data is part of a premarket notification filed by Gettig Pharmaceutical Instrument Co. with the FDA for Gettig Universal Vial Access Pin.
| Device ID | K041232 |
| 510k Number | K041232 |
| Device Name: | GETTIG UNIVERSAL VIAL ACCESS PIN |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | GETTIG PHARMACEUTICAL INSTRUMENT CO. ONE STREAMSIDE PL. WEST Spring Mills, PA 16875 -0085 |
| Contact | James A Benz |
| Correspondent | James A Benz GETTIG PHARMACEUTICAL INSTRUMENT CO. ONE STREAMSIDE PL. WEST Spring Mills, PA 16875 -0085 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-07-22 |
| Summary: | summary |