The following data is part of a premarket notification filed by Pilling Co. with the FDA for Laser Laryngoscope Dedo Articula. & Feder Dedo Ex.
Device ID | K882930 |
510k Number | K882930 |
Device Name: | LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX |
Classification | Laryngoscope, Rigid |
Applicant | PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Contact | Leland J Wimer |
Correspondent | Leland J Wimer PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-13 |
Decision Date | 1988-08-16 |