The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Ent Needles, Tonsil Syringes & Needles.
| Device ID | K951395 |
| 510k Number | K951395 |
| Device Name: | KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Renate A Maclaren |
| Correspondent | Renate A Maclaren KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | EOX |
| Subsequent Product Code | EOB |
| Subsequent Product Code | EOQ |
| Subsequent Product Code | ERA |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-28 |
| Decision Date | 1995-05-09 |