The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Pilot Tube Repair Kit.
| Device ID | K113644 |
| 510k Number | K113644 |
| Device Name: | PILOT TUBE REPAIR KIT |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Doris F Walter |
| Correspondent | Doris F Walter INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-12 |
| Decision Date | 2012-01-26 |
| Summary: | summary |