The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Arthroscopic Telescopes.
Device ID | K943052 |
510k Number | K943052 |
Device Name: | ARTHROSCOPIC TELESCOPES |
Classification | Arthroscope |
Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Betty Johnson |
Correspondent | Betty Johnson KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-27 |
Decision Date | 1995-05-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048551115060 | K943052 | 000 |
04048551113431 | K943052 | 000 |
04048551113189 | K943052 | 000 |
04048551111970 | K943052 | 000 |
04048551111635 | K943052 | 000 |
04048551111628 | K943052 | 000 |
04048551110744 | K943052 | 000 |
04048551110737 | K943052 | 000 |
04048551096567 | K943052 | 000 |
04048551093405 | K943052 | 000 |
04048551115138 | K943052 | 000 |
04048551115145 | K943052 | 000 |
04048551115152 | K943052 | 000 |
04048551110836 | K943052 | 000 |
04048551405086 | K943052 | 000 |
04048551405062 | K943052 | 000 |
04048551405048 | K943052 | 000 |
04048551404560 | K943052 | 000 |
04048551329528 | K943052 | 000 |
04048551255308 | K943052 | 000 |
04048551115176 | K943052 | 000 |
04048551115169 | K943052 | 000 |
04048551020333 | K943052 | 000 |