The following data is part of a premarket notification filed by Scitech Industries Partnership with the FDA for Scitech Bi-manual Adapter Clips.
Device ID | K910088 |
510k Number | K910088 |
Device Name: | SCITECH BI-MANUAL ADAPTER CLIPS |
Classification | Apparatus, Cautery, Radiofrequency, Battery-powered |
Applicant | SCITECH INDUSTRIES PARTNERSHIP 28 SOMERSET DR. Woodcliff Lake, NJ 07675 |
Contact | John D Dugan |
Correspondent | John D Dugan SCITECH INDUSTRIES PARTNERSHIP 28 SOMERSET DR. Woodcliff Lake, NJ 07675 |
Product Code | HQQ |
CFR Regulation Number | 886.4100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-09 |
Decision Date | 1991-04-08 |