The following data is part of a premarket notification filed by Frontline Medical Corp. with the FDA for Combibag Manual Resuscitator.
| Device ID | K851171 |
| 510k Number | K851171 |
| Device Name: | COMBIBAG MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | FRONTLINE MEDICAL CORP. 8501 65TH ST. NORTH Pinellas Park, FL 34665 |
| Contact | Foster |
| Correspondent | Foster FRONTLINE MEDICAL CORP. 8501 65TH ST. NORTH Pinellas Park, FL 34665 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-22 |
| Decision Date | 1985-09-06 |