The following data is part of a premarket notification filed by Instrumed International, Inc. with the FDA for Instrumed Forceps Obsterical, Model# 46-5xxx, Ob-xxxx.
| Device ID | K100517 |
| 510k Number | K100517 |
| Device Name: | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX |
| Classification | Forceps, Obstetrical |
| Applicant | INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173 |
| Contact | Michael Massong |
| Correspondent | Michael Massong INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173 |
| Product Code | HDA |
| CFR Regulation Number | 884.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-23 |
| Decision Date | 2010-04-29 |
| Summary: | summary |