The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Jahn Ventilation Tube.
Device ID | K900267 |
510k Number | K900267 |
Device Name: | JAHN VENTILATION TUBE |
Classification | Tube, Tympanostomy |
Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Robert F Games |
Correspondent | Robert F Games SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | ETD |
CFR Regulation Number | 874.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-18 |
Decision Date | 1990-06-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00821925014688 | K900267 | 000 |
00821925014367 | K900267 | 000 |