The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Extraction Bag.
Device ID | K953549 |
510k Number | K953549 |
Device Name: | KSEA EXTRACTION BAG |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 91 CARPENTER HILL RD. Charlton, MA 01507 -3578 |
Contact | Marika Anderson |
Correspondent | Marika Anderson KARL STORZ ENDOSCOPY-AMERICA, INC. 91 CARPENTER HILL RD. Charlton, MA 01507 -3578 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-28 |
Decision Date | 1995-08-21 |