The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Led Headlight.
Device ID | K031548 |
510k Number | K031548 |
Device Name: | LED HEADLIGHT |
Classification | Light, Headband, Surgical |
Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
Contact | David Klementowski |
Correspondent | David Klementowski WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
Product Code | FSR |
CFR Regulation Number | 886.4335 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-16 |
Decision Date | 2003-08-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00732094073089 | K031548 | 000 |
00732094004571 | K031548 | 000 |
00732094001679 | K031548 | 000 |
00732094001723 | K031548 | 000 |
00732094002485 | K031548 | 000 |
00732094002492 | K031548 | 000 |
00732094041835 | K031548 | 000 |
00732094071818 | K031548 | 000 |
00732094072143 | K031548 | 000 |
00732094072150 | K031548 | 000 |
00732094072167 | K031548 | 000 |
00732094072174 | K031548 | 000 |
00732094072198 | K031548 | 000 |
00732094073065 | K031548 | 000 |
00732094073072 | K031548 | 000 |
00732094004564 | K031548 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LED HEADLIGHT 90894279 not registered Live/Pending |
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