The following data is part of a premarket notification filed by Laurel Medical Corp. with the FDA for Sofsens(tm) Model Lmp-100 Intrauterine Pres. Trans.
| Device ID | K893503 |
| 510k Number | K893503 |
| Device Name: | SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS |
| Classification | Transducer, Pressure, Intrauterine |
| Applicant | LAUREL MEDICAL CORP. 607 WEST TRAVELERS TRAIL Burnsville, MN 55337 |
| Contact | E Palmquist |
| Correspondent | E Palmquist LAUREL MEDICAL CORP. 607 WEST TRAVELERS TRAIL Burnsville, MN 55337 |
| Product Code | HFN |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-05 |
| Decision Date | 1989-06-12 |