The following data is part of a premarket notification filed by Circon Acmi with the FDA for Bullard Intubating Laryngoscope Lar-a & Lar-p.
| Device ID | K883819 |
| 510k Number | K883819 |
| Device Name: | BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P |
| Classification | Laryngoscope, Rigid |
| Applicant | CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Contact | Taylor, Pe |
| Correspondent | Taylor, Pe CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-08 |
| Decision Date | 1988-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925008823 | K883819 | 000 |
| 00821925003453 | K883819 | 000 |