The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Endoscope Holder.
Device ID | K990334 |
510k Number | K990334 |
Device Name: | KSEA ENDOSCOPE HOLDER |
Classification | Endoscope Holder |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Kevin A Kennan |
Correspondent | Kevin A Kennan KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | OCV |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-03 |
Decision Date | 1999-03-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048551410912 | K990334 | 000 |
04048551422335 | K990334 | 000 |
04048551422328 | K990334 | 000 |
04048551255902 | K990334 | 000 |
04048551107539 | K990334 | 000 |
04048551405109 | K990334 | 000 |
04048551251669 | K990334 | 000 |
04048551193679 | K990334 | 000 |