The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Palmer Obstetric Brace.
| Device ID | K864194 |
| 510k Number | K864194 |
| Device Name: | PALMER OBSTETRIC BRACE |
| Classification | Table, Obstetric (and Accessories) |
| Applicant | AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Contact | David A Putz |
| Correspondent | David A Putz AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Product Code | KNC |
| CFR Regulation Number | 884.4900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-27 |
| Decision Date | 1987-01-14 |