The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Laryngascopes, Forceps, Micro Suction Tube & Refle.
| Device ID | K853708 |
| 510k Number | K853708 |
| Device Name: | LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE |
| Classification | Forceps, Ent |
| Applicant | DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | Jarvis Cribb |
| Correspondent | Jarvis Cribb DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | KAE |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-04 |
| Decision Date | 1986-02-14 |