The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Ln 100 Breast Marker.
| Device ID | K872319 |
| 510k Number | K872319 |
| Device Name: | LN 100 BREAST MARKER |
| Classification | Tape, Measuring, Rulers And Calipers |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Clyde T Marrangoni |
| Correspondent | Clyde T Marrangoni INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | FTY |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-17 |
| Decision Date | 1987-08-11 |