The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for V. Mueller Obstetrical (ob) Forceps.
Device ID | K951529 |
510k Number | K951529 |
Device Name: | V. MUELLER OBSTETRICAL (OB) FORCEPS |
Classification | Forceps, Obstetrical |
Applicant | BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. Mcgaw Pk, IL 60085 |
Contact | Nicole M Clark |
Correspondent | Nicole M Clark BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. Mcgaw Pk, IL 60085 |
Product Code | HDA |
CFR Regulation Number | 884.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-03 |
Decision Date | 1995-08-04 |