The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Pullen Plastic-pore Plugs.
Device ID | K772066 |
510k Number | K772066 |
Device Name: | PULLEN PLASTIC-PORE PLUGS |
Classification | Tube, Tympanostomy |
Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ETD |
CFR Regulation Number | 874.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-01 |
Decision Date | 1977-12-20 |