The following data is part of a premarket notification filed by Med-plastics Intl., Inc. with the FDA for Pediatric Gas Sampling.
| Device ID | K932577 |
| 510k Number | K932577 |
| Device Name: | PEDIATRIC GAS SAMPLING |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
| Contact | Terry Rosenkoetter |
| Correspondent | Terry Rosenkoetter MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-27 |
| Decision Date | 1993-07-22 |