The following data is part of a premarket notification filed by Intl. Medical Devices Ltd. with the FDA for Pedia-thor Thoracostomy Kit.
| Device ID | K913540 |
| 510k Number | K913540 |
| Device Name: | PEDIA-THOR THORACOSTOMY KIT |
| Classification | Syringe, Piston |
| Applicant | INTL. MEDICAL DEVICES LTD. 11845 WEST OLYMPIC BLVD. WESTSIDE TOWERS SUITE 1000 Los Angeles, CA 90064 |
| Contact | Jay Geller |
| Correspondent | Jay Geller INTL. MEDICAL DEVICES LTD. 11845 WEST OLYMPIC BLVD. WESTSIDE TOWERS SUITE 1000 Los Angeles, CA 90064 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1992-04-09 |