The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Integrated Drive/pump System For Otolaryngology.
| Device ID | K981637 |
| 510k Number | K981637 |
| Device Name: | INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-08 |
| Decision Date | 1998-07-20 |
| Summary: | summary |