The following data is part of a premarket notification filed by 31st. Centruy Medical Corp. with the FDA for 31st. Centruy Medical Corp Time Buyer 428905 Us Pe.
| Device ID | K853345 |
| 510k Number | K853345 |
| Device Name: | 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE |
| Classification | Needle, Emergency Airway |
| Applicant | 31ST. CENTRUY MEDICAL CORP. 435 OLD HICKORY DR. Pittsburgh, PA 15235 |
| Contact | Anthony Servello |
| Correspondent | Anthony Servello 31ST. CENTRUY MEDICAL CORP. 435 OLD HICKORY DR. Pittsburgh, PA 15235 |
| Product Code | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-10-01 |