The following data is part of a premarket notification filed by Med-tek Corp. with the FDA for Anesthesia Breathing Bags Sizes 1/2, 1,2,3 Liter.
| Device ID | K894906 |
| 510k Number | K894906 |
| Device Name: | ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER |
| Classification | Bag, Reservoir |
| Applicant | MED-TEK CORP. 6685 NORTH SIDNEY PLACE Glendale, WI 53209 |
| Contact | Alan E Whitmarsh |
| Correspondent | Alan E Whitmarsh MED-TEK CORP. 6685 NORTH SIDNEY PLACE Glendale, WI 53209 |
| Product Code | BTC |
| CFR Regulation Number | 868.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-01 |
| Decision Date | 1989-09-18 |