The following data is part of a premarket notification filed by Mic Medical Corp. with the FDA for Palmer Obstetic Brace.
Device ID | K844183 |
510k Number | K844183 |
Device Name: | PALMER OBSTETIC BRACE |
Classification | Table, Obstetric (and Accessories) |
Applicant | MIC MEDICAL CORP. 2775 N. 32ND ST. Milwaukee, WI 53210 |
Contact | Michael Kryshak |
Correspondent | Michael Kryshak MIC MEDICAL CORP. 2775 N. 32ND ST. Milwaukee, WI 53210 |
Product Code | KNC |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-26 |
Decision Date | 1985-02-04 |