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510(k) K821291

PEDERSON VAGINAL SPECULA by Conphar, Inc. — Product Code HDF

K821291 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "PEDERSON VAGINAL SPECULA". The FDA issued a decision of Substantially Equivalent on May 24, 1982. The device falls under product code HDF (Speculum, Vaginal, Metal), a Class I device regulated under 21 CFR 884.4520. Conphar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1982
Date Received
May 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Metal
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type

Other clearances by Conphar, Inc.

  • K821825 — CONPHAR SILICONE FEEDING TUBE (August 10, 1982)
  • K821295 — OLSEN HEGAR NEEDLE HOLDERS (June 3, 1982)
  • K821289 — MAYO-HEGAR NEEDLE HOLDER (June 3, 1982)
  • K821354 — CONPHAR MAYO HEGAR NEEDLE HOLDER (June 3, 1982)
  • K821285 — SPLINTER FORCEPS 4 1/2 (May 28, 1982)
  • K821248 — ROCHESTER PEAN FORCEPS (May 28, 1982)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K821282 — THUMB DRESSING FORCEPS 5 (May 28, 1982)
  • K821298 — BACKHAUS CLAMP, 3 1/2 (May 28, 1982)
  • K821276 — MAYO SCISSOR CURYED 5 1/2 (May 28, 1982)

Other clearances for product code HDF

  • K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (February 28, 1994)
  • K902019 — MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (June 7, 1990)
  • K891041 — MIYA SPECULUM (March 22, 1989)
  • K891044 — LASER SPECULA (March 17, 1989)
  • K890375 — VAGINAL SPECULUM (February 13, 1989)
  • K862478 — HAYES VAGINAL SHIELD (November 24, 1986)
  • K853640 — WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL (October 29, 1985)
  • K851799 — 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA (May 22, 1985)
  • K843388 — WELLINGTON HOSPITAL PATTERN SELF-RETAIN (October 1, 1984)
  • K821297 — GRAVES SPECULA (May 24, 1982)

FDA data resources